i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are… — Class II medical device recall Z-2361-2015
Terminated recall by Abbott Point Of Care Inc., reported 2015-08-19, distributed nationwide. Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially de
| Recall number | Z-2361-2015 |
|---|---|
| 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 | 2015-06-15 |
| Classified | 2015-08-10 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BR, CH, CL, CN, CR, DE, GB, GR, HK, IE, IL, IN, IT, JO, KR, KW, LB, MA, MX, NG, PL, PT, QA, RU, SA, SG, SI, TN, TR, TW |
| Quantity | 423,168 cartridges |
Product
i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
Reason for recall
Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/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-2361-2015. 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.