Recall Z-0669-2019 ยท MRG System, Test, Vitamin D
Abbott Ireland Diagnostics Division
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
| 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 | 760 units |
| Distribution | AR, FL, GA, MD, OK, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls Abbott Laboratories, Aug 12, 2016 |