Recall Z-2208-2019 ยท DBF Ferritin, Antigen, Antiserum, Control
Abbott Ireland Diagnostics Division
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
| Date | Nov 21, 2018 |
| Status | Terminated |
| Reason | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. |
| Root cause | Device Design |
| Action | The firm, Abbott, initiated the recall by a "Product Recall Urgent - Immediate Action Required" letter dated 11/21/2018 to its consignees. The letter explained the product, problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units, use an alternate lot of the product if available; manually inspect each reagent cartridge in inventory before use; complete and return the Customer Reply Form via FAX #: 18007770051 or email: QAGCO@abbott.com. Even if you no longer have the instrument(s), please return the compl |
| Quantity | 216 units |
| Distribution | US Distribution to states of: AR, FL, GA, MD, OK and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983759 | ABBOTT ARCHITECT FERRITIN Abbott Laboratories, Dec 7, 1998 |