Alere INRatio PT/INR System Professional Model Numbers: 0100004… — Class I medical device recall Z-2354-2016
Terminated recall by Alere San Diego, Inc., reported 2016-08-31, distributed nationwide. Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Te
| Recall number | Z-2354-2016 |
|---|---|
| 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 | 2016-07-11 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BE, BR, CA, CL, CN, CO, EG, ES, FR, HK, ID, IL, IN, IT, JP, KR, MY, NL, RU, SG, TH, TT, TW, UA, UY, VN, ZA |
| Model numbers | 0100004 |
Product
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.
Reason for recall
Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System 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-2354-2016. 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.