Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system 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 Alere INRatio PT/INR Test Strips (part numbers 0100071 and 0100139) and the Alere INRatio PT/INR System Professional. The recall involves 77,342 units of 12-strip boxes and 308,947 units of 48-strip boxes. The products were distributed worldwide, including the US, Canada, South America, the EU, Asia Pacific, Africa, and the Middle East.
The recall is issued because the 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 conditions or if the instructions in the labeling for performing the test are not followed.
Consumers and healthcare providers should stop using the affected test strips and contact Alere San Diego, Inc. for further instructions or a replacement.
The recalled product
- Product
- Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12…
- Manufacturer
- Alere San Diego, Inc.
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 (1)
- All lots of part numbers: 0100071 and 0100139.
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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