Recall Z-0513-06 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories MPG
ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
| Date | Feb 14, 2006 (initiated Dec 21, 2005) |
| Status | Terminated |
| Reason | There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors. |
| Root cause | Other |
| Action | Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement. |
| Quantity | 181 kits |
| Distribution | Nationwide and internationally to Canada, Australia, Germany and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics, Aug 12, 2004 |