FDA Recall
Terminated
Alinity i Progesterone Reagent Kit, List Number 08P3620
Recall: Z-0668-2019
·
Initiated November 21, 2018
Recall
- Recall Number
- Z-0668-2019
- Event Number
- 81632
- Firm
- Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland
- FEI Number
- 3005094123
- Product Code
- JLS
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 21, 2018
- Terminated
- April 1, 2021
Description
Alinity i Progesterone Reagent Kit, List Number 08P3620
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.
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.
Distribution
AR, FL, GA, MD, OK, VA
Quantity
157 units