Recall Z-0293-04 ยท CGN Acid, Folic, Radioimmunoassay
Abbott Laboratories HPD/ADD/GPRD
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA
| Date | Jan 6, 2004 (initiated Nov 23, 2003) |
| Status | Terminated |
| Reason | Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing. |
| Root cause | Other |
| Action | Abbott notified their international affiliates via e-mail on 11/23/03. Important Product Information letters dated 11/24/03 will be sent to the end users by the affiliates, informing them of the possible methotrexate carryover to subsequent samples and falsely elevated folate values. |
| Quantity | 3,475 packs |
| Distribution | There was no U.S. distribution. The product was internationally distributed through Abbott subsidiaries in Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.