Alere INRatio2 PT/INR Professional Test Strips — Class I medical device recall Z-1546-2014
Terminated recall by Alere San Diego, Inc., reported 2014-05-14, distributed nationwide. Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic
| Recall number | Z-1546-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-05-08 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2017-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 99,795 total |
| Model numbers | 99008G2 |
Product
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).
Reason for recall
Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1546-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.