Recall Z-0716-2013 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Point of Care Canada Limited
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect
| Date | Jan 24, 2013 (initiated Nov 1, 2012) |
| Status | Terminated |
| Reason | APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. |
| Root cause | Error in labeling |
| Action | APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information. |
| Quantity | 560 boxes (25 cartridges in each box) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST I-Stat Corporation, Sep 2, 2003 |