Alere INRatio2 Test Strips Recalled for Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device that may provide inaccurate results for warfarin therapy monitoring, which is a significant injury risk. The agency classification is Class I, which per the rubric mandates a score of at least 4.
Plain-English summary
Alere San Diego, Inc. is recalling approximately 99,795 units of Alere INRatio2 PT/INR Professional Test Strips, Model Number 99008G2. These test strips are used by health care professionals for the quantitative determination of the international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time. The affected lots were packaged between August 22, 2013, and March 28, 2014, and have expiration dates ranging from April 30, 2014, to January 31, 2015. The products were distributed nationwide in the United States.
The recall was initiated because the test strips may report an inaccurately low INR result. The source text notes that several patients had a therapeutic or near-therapeutic INR when tested with the Alere INRatio2 PT/INR Professional Test Strip, but a significantly higher INR (outside of the therapeutic range) when the test was performed by a central laboratory. This discrepancy could lead to incorrect monitoring of warfarin therapy.
Health care professionals using these test strips should stop using the affected lots and contact Alere San Diego, Inc. for further instructions. Patients should consult their healthcare providers regarding their INR monitoring and warfarin therapy.
The recalled product
- Product
- Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary…
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 99,795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- including the following: 324810
- 324811
- 324812
- 327543
- 327544
- 327549
- 328109
- 328705
- 328707
- 330238
- 330852
- 331340
- 331916
- 331922
- 332841
- 332842
- 332843
- 332959
- 333362
- 333654
Distribution
Distributed nationwide across the United States.
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