Recall Z-1204-06 ยท DBF Ferritin, Antigen, Antiserum, Control
Abbott Laboratories MPG
ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
| Date | Jul 4, 2006 (initiated Jun 6, 2006) |
| Status | Terminated |
| Reason | Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2). |
| Root cause | Other |
| Action | Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachme |
| Quantity | 10,725 kits |
| Distribution | Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983759 | ABBOTT ARCHITECT FERRITIN Abbott Laboratories, Dec 7, 1998 |