Recall Z-0180-2012 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Point Of Care Inc.
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
| Date | Nov 10, 2011 (initiated Sep 29, 2011) |
| Status | Terminated |
| Reason | i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results. |
| Root cause | Material/Component Contamination |
| Action | APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees. The letter identified the affected product and explained the background of the problem. Customers are to discontinue use of the cartridges from the lots identified. All unused product will be credited and should be returned as instructed on the attached Business Reply Card. If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well. APOC shipped replacement product in order to minimize any disruption. If replacement product has not bee |
| Quantity | 1,688,755 cartridges |
| 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 |