Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling Alinity i Total Beta-hCG Reagent Kit (List Number 07P5121) due to a manufacturing issue that can damage the bottle neck in some reagent cartridges. The affected product was distributed to Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia, with 27 units involved. The recalled lot is identified by UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00.
If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 27 units Lot/code info: UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.