Alere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class I, which the rubric defines as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Alere San Diego, Inc. is recalling 231,967 INRatio 2 PT/INR Professional and Home Monitoring Systems. The affected products include part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A. These systems are intended for in vitro diagnostic use to monitor the effect of warfarin on clotting time.
The recall is due to a potential issue where the INRatio 2 Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). The source text notes that this issue can arise if the patient has certain medical conditions or if the instructions in the labeling for performing the test are not followed.
The products were distributed worldwide, including the US, Canada, South America, the EU, Asia Pacific, Africa, and the Middle East. The source text does not specify a consumer action or contact information for the recall.
The recalled product
- Product
- INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement M
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 231,967
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 (7)
- All lots of part numbers 0200431
- 0200432
- 0200433
- 0200457
- 55112
- 55131
- and 55128A.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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