Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.
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: "Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2…"
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of Alere INRatio/INRatio2 PT/INR Test Strips. The recall covers model numbers 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, and 99008G7. The product is distributed worldwide, including the United States and numerous foreign countries.
The recall is being initiated because patients using the Alere INRatio/INRatio2 PT/INR System received therapeutic or near-therapeutic INR results, but subsequent tests performed by a central laboratory showed significantly higher INR values outside the therapeutic range. This discrepancy indicates that the test strips may provide inaccurate clotting time measurements.
The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by individuals taking warfarin and other oral anticoagulant therapy to monitor their blood clotting time. The system is not intended for screening purposes. Consumers and healthcare providers should stop using the recalled test strips and contact Alere San Diego or their healthcare provider for instructions on how to proceed with monitoring.
The recalled product
- Product
- Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is…
- 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 All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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