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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical…"
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…
- 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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