i-Stat CK-MP cartridges Abbott Point of Care Inc — Class II medical device recall Z-2171-2012
Terminated recall by Abbott Point Of Care Inc., reported 2012-08-15, distributed in AZ, CO, GA. The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric press
| Recall number | Z-2171-2012 |
|---|---|
| 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 | 2012-02-01 |
| Classified | 2012-08-09 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-02-08 |
| Distributed | AZ, CO, GA |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CH, CL, CN, CO, CR, DE, DO, ES, FI, FR, GB, GR, HK, HN, IE, IN, IT, KR, KW, MX, NG, NO, OM, PE, PL, PT, PY, QA, RU, SA, SE, SG, SV, TH, TW, ZA |
Product
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
Reason for recall
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
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-2171-2012. 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.