Device product
Alinity i Estradiol Reagent Kit, List Number 07P5020
Z-0667-2019
Product summary
- Event
- Event 81632
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79 units
- Official record key
device-enforcement:Z-0667-2019
Official wording
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.
Code information: UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00
Distribution pattern: AR, FL, GA, MD, OK, VA
Derived failure modes
-
Unknown
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.