Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc — Class II medical device recall Z-0451-2014
Terminated recall by Abbott Point Of Care Inc., reported 2013-12-11, distributed nationwide. Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit inc
| Recall number | Z-0451-2014 |
|---|---|
| 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 | 2013-10-28 |
| Classified | 2013-12-04 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CH, CL, CN, DE, ES, FI, FR, GB, GR, HK, IE, IT, KR, KW, MX, NG, NZ, PE, PL, PT, QA, RU, SA, SE, SG, TR, TW, ZA |
| Lot numbers | R13149A, R13151, R13151A |
Product
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Reason for recall
Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
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-0451-2014. 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.