What's up with the new FDA warning letter to Siemens? Are assays going to be pulled from the Centaur? Sounds like the Beckman thing.
At least China is a bright spot for DX, Australia doesn't seem to be.
This post is hilarious re the mood of DX in the USA:
"Ironically, the FDA letters are about the only outstanding thing about Siemens these days."
I have tried to make this point before. There is alot more to Siemens DX than the US, or LA or Tarrytown or Glasgow, etc. Keep a close eye on the DX China strategy. Last year's results were driven by the performance in China and Siemens may have a far more complex plan for China than current activities indicate and a mucn longer time line. If you put aside the Euro-Americ-centric thinking and look carefully at the state of the DX business today, it is possible to envision a future in which China plays a large role and in which American and European facilities are primarily marketing, sales and service organizations.
In just three years I work for Siemens DX, I grew from analyst to "director and above", from work on my own to have more than 10 direct reports, more importantly I got to choose to work at my home country China. The only thing I can say is
I love Siemens most, and I love DX moster. Cheers.
Ironically, the FDA letters are about the only outstanding thing about Siemens these days.
Interesting. Didn't know Siemens has outstanding warning letters...
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The link to Siemens' "Urgent Field Safety Notice: Ambient Temperature Effects on ADVIA Centaur Assays, November 2012" is below.
FDA appears to be concerned about temperature effects on all manufacturers' instruments now.
"The following information requires immediate attention regarding new room temperature operating requirements, for the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP assays in Table 1.
Operation outside of the new range can impact assay performance.
The operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F). The assays in Table 1 can produce inaccurate results when performed within this operating range. A change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
If your laboratory is unable to maintain these temperature ranges, do not continue reporting results for the assays listed in Tables 3 and 4."
BEc Miami assembly lines don't speak or read English procedures in Chinese, Management repented immigrants with foreclosure accent.
Wanna be. Mediocre, supervisor the has sexual relations with employee and get her pregnant.
10000 incident report per year..
Beckman has recalls on recalls no one beats Beckman 10 recalls on just dxh 800
Is this a big deal, or is this typical for this industry?
It's for the Centaur
on what instrument(s)?
Siemens just issued a class II recall for BNP, CA 27.29, DHEAS, Digitoxin, Folate, and Theophylline, regarding acceptable ambient room temperature on their package inserts from 18-30 degrees C has been reduced to 20-25 degrees C or 18-26 for DHEAS.
Temperatures outside the new range may increase or decrease the results based on the temperature.
Sounds like the same issues with the Beckman DXI.
Only time will tell, won't it?
It's not MY rumor!
I'm not a competitor, just an ex-siemens employee
who watches the rumor mill.
I also have a pretty good BS meter after being in this industry for 25 years.
Doesn't matter who's line anyone believes. When events happen, then we'll all know for sure. Given many of the postings here, my comment was simply a matter of healthy skepticism about your 'rumour'. Who else would post such a rumour anyway?
Great company line.
Do you really believe that crap?
I see. But who are you? Where did you get this information? Are you a competitor, perhaps? An insider who wants to bite the hand that feeds him or her or maybe to wake management up to a real problem? I suspect that Siemens has diverted a significant amount of its manpower into doing what it takes to satisfy the FDA and they will get it done, regardless of what it takes.
I hear since Siemens has not made any process improvements, the Axe is getting ready to fall by year end... Centaur menu will be cut significantly.
A surprise visit usually means they are sending in a team to get proof they know is there to put together an FDA concent letter!
Those morons will still find some way to screw it up.
A surprise visit that you know about already? Hmmmmmmm some surprise.
FDA is making a surprise visit to one of our plants this week. Hopefully, this will go better than the others.
"Is there any news on the warning letters? Sounds like a lot of grousing."
Watch out Siemens. The vultures are circling up above. Hey, competition .... do your own homework. Don't come here and expect Siemens to give you all the details. Nice try.
The mere lack of any additional public information on this issue is probably good news for Siemens.
Is there any news on the warning letters? Sounds like a lot of grousing.
Give Mikey some more stock options.
He'll need the money when the big boys in Germany figure out how clueless he is. Maybe then they'll cut all the other 'managers', zone directors, sales directors, that have led them down this wonderful path.
Following the german/bayer model seems to be working well, huh?
Sounds to me like roche is eating siemens alive.
Getting the beckman customers and stealing the siemens ones.
They seem to be doing all the right things while siemens
just keeps going by the playbook.
Why hasn't someone realized the playbook is not working?
Ignoring long term customers and concentrating on customers
they will never get is not working.
How about at Roche?
In dx the best and brightest are at 10 watts.
Any more news on this? In the imaging division we are getting bludgened for these letters as well. They do not want FDA to put a target on Siemens back in general. I agree - but why does it take SO long for supposedly the best and brightest at Siemens (mngt) to get that externally there is only one Siemens? Maybe it speaks to the fact that the best and brightest are NOT at the top of Siemens, but rather the best marketeers and politicians. The good news is if true, this is not sustainable and changes eill need to be made. Good luck DX! Let's tear down the silos!
It's worse than drifting, they are actually rowing towards a waterfall. Short term, things make sense. They're moving fast and all management cares about is speed and very short term wins (at least that is what they market to us, the short term wins). Long term, for those who are in the know, they will time their jump and parachute out of the boat when it hits the waterfall.
It's a strange way to run a company, but I don't think Siemens has been at Mergers and Acquisitions long enough to really know what it takes to make them successful. Not to mention, they bolted on an entirely new business and entirely new culture to their ocean liner, one that's big enough to cause the entire liner to take on water.
Honestly, what can they do at this point? Their management team basically are business consultants at this point, and all they know is how to pull on levers for short term gains. They don't have the skill set or vision to chart out the river - hence they are heading for rough waters and waterfalls, at a fast clip! Perhaps you could even say that of the entire market at this point...
Isn't it clear by now that Siemens is a complete failure at internal communication. They don't tell people what they need to do in order to do their jobs and what they do tell the employees is a bunch of rah-rah, rally-'round-the-flagpole-boys stuff that either goes over the employees heads, passes through their heads, or is mocked. They can lay off as many people as they want, reorganize every six months, but right now it is pretty clear that Siemens is just not in control of their own business. Too much of it sounds like it's just drifting.
sales employees have yet to be told about the letter and a 'follow the playbook' response.
would you expect anything else from this bunch of losers?
So what has Siemens proposed to do to remedy the FDA Warning Letter? Seems like there has been nothing resolved. Everyone is telling me it's okay and it's paperwork.
"If a deep investigation is undertaken at the TTN site by FDA, its more than likely that R&D will shut down. Its sad because there are talented scientist there that simply are treat like simpleton technicians."
The preceeding is an example of pure nonsense. Has the FDA EVER shut down an entire R&D department? They have forced product withdrawals and shut down manufacturing facilities, but I have never heard on an R&D department being shut down completely. The above sounds like it cam either from a 'simpleton' competitor or a nervous nellie employee.
If a deep investigation is undertaken at the TTN site by FDA, its more than likely that R&D will shut down. Its sad because there are talented scientist there that simply are treat like simpleton technicians.
If what you say is true, and I have no reason to doubt you, then two things occur to me.
Based on all of the negative comments I've seen about various Vitamin D assays and contraversies about the best form(s) of Vitamin D to measure, the assays themselves will have to improve considerably, in particular in the low end.
Until that happens, it seems to me that people are wasting alot of time talking about what I continue to believe is a small percentage of overall revenue and then concluding that Vitamin D assays are essential to the financial well being of the company.
The good news here is that since the market is still small relative to its future potential, the various companies in the Vitamin D business have some time to improve the methods. As the diagnostic value of testing increases, so will the performance expectations of customers. So any forward looking company should be keeping a close eye on new developments and working on method improvemnt. Companies that have been around for a while are used to having to improve methods. As antibody specificity improved, cross-reactivity was no longer tolerated. Assays like TSH and C-reactive protein had second and third generation methods which increased sensitivity at the low end by orders of magnitude. So your posting here about the potential should have some value to a smart company who will pick up on it and follow whats going on in the Vitamin D field. You should be proud. It is fairly rare that anyone posts anything of real use here.
Well sir/ ma'am, I certainly underestimated your understanding of how significant the possibilities are for Vit-D, and I agree the market situation is never reflective of the true validity of an analytes testing value. That being said, I'm on the side thinking Vit-D can be the real deal. But then, it sure did look much the same for interferon 25 years ago didn't it? I think we all kinda felt like the researchers had really stumbled on to something. Years later and a thousand+ NIH grants later, what happened? Multi-species of interferon, difficulty in replicating the exact biological functioning form, difficulty in procurring/manufacturing sufficient quantities, poor clinical correllation trials with doses and results, etc, etc. and now no one talks about interferon. So yes, it can happen to the most promising substances that we are witness to, but something tells me it may truly be different with Vit-D. The pieces not even studied yet all seem to fall into place regardless, especially when you factor in that what was biologically best historically for our species may not actually be the best for a human living well past what his body was adapted to for thousands of generations. We have changed all the rules so fast, so the game must now be played with totally different strategies. It is actually a fascinating time for researchers as they will be playing outside all the rules that clinicians have abided by for all of medical history. Some really big things may well be ahead for all of us who live long enough to see them.
I have no argument with what you say and am well aware of the research and clinical studies that are under way that may show many beneficial effects of maintaining proper Vitamin D levels. I am also very aware that our rapidly changing technology has, for perhaps the first time in human history, created a situation in which mankind must adapt far more rapidly than evolution can permit and recognize the multiple negative affects it seems to be having on our species. Up until roughly 200 years ago, virtually all work was done with muscles (ours or those of horses, oxen, etc.).
Nonetheless, my comments were directed towards the situation today in which the necessity for Vitamin D is relatively rare and can easily see the possibility that you suggest that testing volume might increase sharply in the future if research shows that testing can lead to treatments with positive outcomes (tests that cannot alter the patient outcome or situation should never be performed). The market always changes as new data supports different levels of testings; sometimes increasing and sometimes decreasing testing. Occasionally, companies get overexcited about a 'new' analyte and things don't quite pan out. As an example, in the late 80s-early 90's there was alot of excitement about Apolipoproteins A1 and B. Alot of data suggested that they were better markers than cholesterol and HDL. What happpened? The market never really took off, primarily due to the significantly cost of of Apo A1 and B tests. For a brief time, prostatic acid phosphatase immunoassay was hot, only to be replaced by PSA. (Did you notice that Beckman has just gotten FDA clearance for a new PSA test that they claim is more predictive of more dangerous forms of prostatic cancer? I wonder what they will charge and whether the market will migrate to them). I could also speculate that all of the Vitamin D research that justifies more close monitoring of Vitamin D levels, might also come up with a surrogate analyte that can be measured much less expensively and without all of the issues that I read about at the rumour mill about the various Vitamin D assays on the market today (sounds like they could all use some significant improvement).
My only point was that in today's market, it is hard to imagine that Vitamin D assays are crucial to the bottom line of the major players. I have no reason to doubt that things might change in the future and I completely agree with you when it comes to your comments about modern society and man. (btw, can you imagine if our lifespan was only 30 years nowadays. Only two generations alive at a time rather than 4 or so. A much higher average energy level of the population. Of course, we would be pretty short on wisdom, but the proposition could make for a very entertaining evening discussion that is definitely not appropriate for this thread).
"The need for any Vitamin D test is a tribute to the poor diet and health habits of American"
Obviously there is validity in your statement, but the Vit-D matter is not to be trivialized by such simplistic logic. A whole lot of re-thinking about Vit-D and its effect on the human system is currently under way, and it is far more complicated than just "eating and taking care of one's body". What factor's do you say?
Chemical/ toxic agents
Advanced medical care
This would take volumes of text to elaborate on, but your puzzled reaction to the above list exemplifies the lack of understanding most poeple have about the potential of Vit-D research. Yes, it is possible the actual benefits of a much fuller understanding of Vit-D may not pan out to be much more than a fad.........but I wouldn't count on it. Here is a simple out-of-the-box reflection on the human condition that may open up some eyes;
Getting enough sunshine: Yes, going to the beach will help, but the fact that all of us cover 80-90% of our bodies on a daily basis means that our exposure to sufficient sunlight is greatly reduced. Think about the thousands of years of evolution, basically adapting a naked humanid body to exposure to sunlight. Then in a couple ticks of the evolutionary clock we go from naked to covered up and getting the bulk of our daytime "light" from CFL's that emit no ultra violet light wavelengths. And further more, the hypocondriacs are telling everyone to stay out of the sun in order to preserve our skin texture. No, the problem is we are living longer than evolution has adapted us for.
Because everything has changed so rapidly for humans, the game has to be changed for our thinking about how best to keep our health for the extended lives we now consider "normal". So the thinkig on Vit-D and many other aspects of health care must also change. Live life for what was best for a H. erectus and you will have the lifespan of that creature; maybe 30 years?
Digressing? Did you mean regressing? In either case, I think if you look at the diet of Americans who are reasonably above the poverty level and compare it to a similar group 20, 30, up to 60 years ago, the average American is not eating as healthful diet today.
I have never known anyone to have a vit D test. Don't you just need to drink milk or spend 10 min in the sun each day? Is scurvy making a comeback too? Wow - America is really digressing...
Sorry, no sniping cause I agree.
The previous post was strictly about the Centaur Vitamin D kit problems and loss of revenue (and customers) Siemens was expecting.
Vitamin D is really just the flavor of the month.
Probably the reason Tarrytown rushed it out the door.
Enjoy your bagel. I like mine toasted with creme cheese.
The need for any Vitamin D test is a tribute to the poor diet and health habits of Americans and others in developed countries. In general, the true need for Vitamin D testing should be fairly rare for people who take care of their bodies. Thus, all of this arguing and sniping at one another on the part of various DX companies who provide Vitamin D is simply a diversion and takes away from the reality that far too much money is being spent by health care plans (insurance) of Vitamin D testing and those costs ultimately work their way down to folks like you and me.
It would also be nice to see what proportion of overall immuno testing volume and what proportion of revenues come from Vitamin D testing. My guess is that both percentages are quite low, making the performance of Vitamin D assays even less relevant to the companies that supply the tests. It may be fun for the scientists and ivory tower experts to argue and discuss every minute detail of Vitamin D testing (it has sure been fun watching the Vitamin D wars here), but keep in mind that neither physicians nor most patients are scientists and they really don't care about all of this esoterica.
I'm sure there will be just tons of pushback on the above statements. I hope y'all don't mind if I have a latte and a bagel while enjoying the (presumably hostile) responses to the above opinions.
Centaur Vitamin D has major problems and the kit is not coming close to what Siemens expected financially. Results are rarely reproducible and much of customer purchases were switched over to Diasorin and Roche. Many at Tarrytown fully expected this to happen before and after the kit hit the market.
For many labs, this kit has already bitten the dust.
Okay, listen up guys......Siemens says it just paper work this FDA stuff. My question is why did Siemens not follow-up on the compliants. Seems the article in the NJM about the B12 should be an indication of what it takes for Siemens to take voluntary action.....so there's now Vista B12 pulled from the market, the obvious PTH and the CKMB both were mentioned in the letter. Now lets put this out there too......how is the Vista Thyroid's and the Centaur Vitamin D working for you all........
"Siemens DX should just write off the US market..."
It kind of seems that the US market has written off Siemens DX first!
"If Siemens is a Costco pizza, DX would be a couple of pepperoni circles. Those who think Siemens executives would have nightmares because of a few warning letters from a US agency, are either too naive or ignorant."
Yes, Siemens DX should just write off the US market and sell only in China. Would solve a lot of their problems.
It seems that all that Siemens has to do to satisfy the FDA is to tighten up on their complaint handling procedures, especially in the 'replace upon complaint' vs. 'recalling' and manufacturing change areas, and go back over areas where there were deficiencies in the past and go through the process and documentation properly. If they are smart they will review their entire quality system for both compliance and efficiency. This assumes they still have the personnel qualified to do all of this.
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