Recall Z-0664-2019 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Abbott Ireland Diagnostics Division
Alinity i TSH Reagent Kit, List Number 07P4830
| 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 | Nonconforming Material/Component |
| Action | The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced. |
| Quantity | 678 units |
| Distribution | AR, FL, GA, MD, OK, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983442 | ABBOTT ARCHITECT TSH Abbott Laboratories, Nov 20, 1998 |