Recall Z-0783-05 ยท CGN Acid, Folic, Radioimmunoassay
Abbott Laboratories MPG
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
| Date | Apr 28, 2005 (initiated Mar 11, 2005) |
| Status | Terminated |
| Reason | concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert. |
| Root cause | Other |
| Action | Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution. |
| Quantity | 2,521 kits |
| Distribution | Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.