I-STAT PT/INR cartridge Abbott Point of Care Inc — Class II medical device recall Z-2157-2012
Terminated recall by Abbott Point Of Care Inc., reported 2012-08-15, distributed nationwide. The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
| Recall number | Z-2157-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Point Of Care Inc., Princeton, NJ, United States |
| Recall initiated | 2012-03-01 |
| Classified | 2012-08-08 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-02-08 |
| Distributed | Nationwide (US) |
Product
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Reason for recall
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
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-2157-2012. 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.