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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may provide inaccurate diagnostic results (INR), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
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 o
- 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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