Recall Z-0364-04 ยท CGN Acid, Folic, Radioimmunoassay
Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); Abbott Laboratories, Abbott Park, IL 60064 USA
| Date | Jul 20, 2004 (initiated Dec 16, 2003) |
| Status | Terminated |
| Reason | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
| Root cause | Other |
| Action | Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx. |
| Quantity | 2,141 kits |
| Distribution | There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023397 | ABBOTT ARCHITECT FOLATE Abbott Laboratories, Dec 16, 2002 |