Alinity i Estradiol Reagent Kit, List Number 07P5020
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling the Alinity i Estradiol Reagent Kit (List Number 07P5020) due to a manufacturing issue that can damage the bottle neck in some reagent cartridges. The affected lots are identified by specific UDI/Lot Numbers listed in the recall documentation. If a bottle neck is damaged, the reagent may fail to load properly when used with the Alinity i instrument.
The recall affects 79 units distributed across Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia. The source document does not specify a remedy or corrective action for affected consumers.
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: 79 units Lot/code info: UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.