Recall Z-1051-2009 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories
AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22
| Date | Apr 15, 2009 (initiated Jan 19, 2009) |
| Status | Terminated |
| Reason | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| Root cause | Employee error |
| Action | Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and disc |
| Quantity | 2,314 kits |
| Distribution | Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060875 | ABBOTT AXSYM TROPONIN-I ADV Abbott Laboratories, Jun 14, 2006 |