Alere INRatio Monitors Recalled for Potential Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR 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 INRatio PT/INR Monitor systems, including the Alere INRatio PT/INR System Professional, INRatio Prothrombin Time (PT) Monitoring System, and Alere INRatio Replacement Monitor. The recall covers 231,967 test systems distributed worldwide, including the United States, Canada, South America, the EU, Asia Pacific, Africa, and the Middle East. The affected products include part numbers 0100004, 0100007, and 0100137.
The recall is being issued because, in certain cases, the INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system, such as a 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.
Consumers and healthcare providers should stop using the affected INRatio monitors and contact Alere San Diego, Inc. for further instructions or a replacement. The devices are in vitro diagnostic monitoring systems used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
The recalled product
- Product
- INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor…
- 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 (3)
- All lots of part numbers: 0100004
- 0100007
- and 0100137.
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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