i-Stat cTnl cartridges Abbott Point of Care Inc — Class II medical device recall Z-2169-2012
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-2169-2012 |
|---|---|
| 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 cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Reason for recall
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Machine access
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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.