Alinity i Progesterone Reagent Kit, List Number 08P3620
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling Alinity i Progesterone Reagent Kit (List Number 08P3620) due to a manufacturing defect that can damage the bottle neck on some reagent cartridges. The affected lots are listed in Appendix A. If the bottle neck is damaged, the reagent may fail to load properly into the Alinity i instrument. The recall affects 157 units distributed across Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia.
The specific lot numbers involved are UDI/Lot Numbers (01)00380740121877 (17)190503(10) 91254UI00 and (01)00380740121877 (17)190618(10)92360UI00. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: AR, FL, GA, MD, OK, VA Quantity: 157 units Lot/code info: UDI/Lot Numbers (01)00380740121877 (17)190503(10) 91254UI00 / 91254UI00 (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.