Recall Z-0666-2019 · DHA System, Test, Human Chorionic Gonadotropin
Abbott Ireland Diagnostics Division
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
| 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 | 27 units |
| Distribution | AR, FL, GA, MD, OK, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System Abbott Laboratories, Oct 23, 2017 |