Alegre INRatio Recall

Does anyone know what is happening with the recall of alere INRatio2 strips. Have there been 3 deaths as a result of incorrect results with this product? It sounds like it is being managed and so the information is not getting to those who need to know....the customers? How can this be allowed to happen in a regulated industry...

We just dumped Alere for the

We just dumped Alere for the Roche analyzer. Tired of this stuff.

This is just the latest in a

This is just the latest in a long string of events ever since RZ went on his rampant run of M&A and got rid of the knowledge base that made the previous products good. It's just a matter of time until Alere falls apart. RZ's patents are starting to expire, his informatics and home-health segment is a drain on the company, and the competition has caught up and passed Alere. Sell, sell, sell!!

Maybe the FDA will look at

Maybe the FDA will look at them again. Not only did they have a recall of this product in Dec last, but they took a beating by FDA on the triage product made in SD. They must be worried....maybe this is why this recall is low profile in Europe. Looks like they are "managing" things again.
Still can't understand how 9 adverse events including 3 fatalities leads to a voluntary withdrawal that is being managed.

How many more hits can this

How many more hits can this product line take before the FDA shut them down?

From their earnings call: Our

From their earnings call:

Our global professional INR revenues were $60 million in 2013 and $13.2 million in Q1 2014 of which $39.9 million and $8.2 million related to US professional revenues. Included in our Q1 results were US revenues of $6.5 million related to sales of INRatio2 test strip which is net of a $1 million reserve for product that may be returned as a result of the recall. We’ve begun working with our customers to supply them with the earlier version of the strip and thus far this has progressed well. Nevertheless, we anticipate an immediate impact of potentially several million in revenue per quarter for the next few quarters.

No idea on revenue, but it

No idea on revenue, but it must be significant. The INRatio system is number 2 in market, after Roche, even though the product performance is reported to have poor lot to lot variability and require a large sample size.

Does anyone know how much

Does anyone know how much revenue Alere generates from the recalled products?

It is true according to the

It is true according to the recall notice sent by Alere, along with six other serious incidents. This is for the new version strips only, Alere# 99008G2. The previous version (which is still used for the home use monitor) is ok. They have been very proactive in getting us the information. The instructions are to STOP using the 99008G2 strips immediately and use an alternate method. The HI100139 strips will be in short supply for a while as they ramp production back up. In the mean time, they recommend sending the tests to a lab or using a competitor's product.
It is scary that this can happen in such a regulated environment, isn't it?

Post new comment

  • Web page addresses and e-mail addresses turn into links automatically.
  • Allowed HTML tags:
      1. Lines and paragraphs break automatically.

    More information about formatting options

    To prevent automated spam submissions leave this field empty.