Recall on Alere INRatio2PT/INR Monitoring System


Class I Recall

The Federal Drug Administration has initiated a recall on Alere INRatio and INRatio 2PT INR Monitoring Systems. This recall is of the Class I variety, which is the most serious type there is. Using one of these devices could ultimately prove to be fatal, if not at the very least exceptionally injurious. It’s so bad, the product line has been discontinued additionally.

Removal From The Market

In an effort to curb negative fallout from this recall, everything will be discontinued related to the INRatio and INRatio2 PT/INR Monitoring systems. This includes test strips. Every available series number is additionally being discontinued and recalled. The products affected have been manufactured and distributed between April 1st, 2008 and July 8th, 2016. Currently some 125,576 12-count test strip kits have been recovered. Some 24,783 have been recovered in the 48 count variety. 236,345 returns of INRatio and INRatio2 Monitors have additionally been recorded.

These handheld devices were designed to monitor the time it takes blood to clot. The measurements are tabulated in PT/INR values of people on Warfarin, also known as Coumadin. This particular system was designed to be used in professional healthcare environments as well as the home.

A Closer Look AT The Reason These Systems Were Recalled

Incorrect results on the low side can be generated in plasma-based laboratories utilizing the INR method. Incorrect readings lead to dosage adjustments which can put patients at risk for fatal bleeding. There are a few reasons such a thing may happen; included in them medical conditions, and improper administration of the test. To date, Alere has not been able to develop a system which adequately monitors patients.

Affected Parties

Those testing at home are definitely at high risk; especially if they are administering their own dosages. Additionally, healthcare providers that have used this system for monitoring blood clotting could make a wrong call. Distributors and retailers of this device will also be affected by this recall.

How To Handle The Situation

For consumers, the first thing you’re going to want to do is get in touch with your healthcare provider and have them help you transition to a new PT/NR testing method. There are “point of care” monitoring systems available from other manufacturers. Additionally, there’s the laboratory INR method that is plasma-based.

In the meantime, good advice for individual users includes:

  • Continuing to use the INRatio system until a replacement device is secured.
  • Following advisements pertaining to recall information when performing subsequent tests. These can be found in the current product insert’s labeling, as well as the MDCN (Medical Device Correction Notification) of 2014’s December.
Health providers additionally have several steps they should take in the event this recall affects them. These include:

  • Make sure patients have a safe and swift transition.
  • Periodically vet INR levels in patients at a plasma-based lab. If the lab results differ, get them on a different INR system.
  • As with individual users, maintain use of INRatio system until new options are available.
Retailers and distributors should maintain their distribution of test strips from Alera’s INRatio. This will allow those patients who require the testing method to have a safe transition. Ultimately, so long as a safe transition method is uncovered, patients are generally at very low risk. Unfortunately, this defect is a sneaky kind that will affect some before they can be properly notified. One last piece of advice: if you or anyone you know uses the INRatio system, inform them of the recall as soon as possible in order that they may act accordingly. It’s just possible that you could save someone’s very life.

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