Alinity i Free T4 Reagent Kit, List Number 07P7030
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling Alinity i Free T4 Reagent Kit, List Number 07P7030, due to a manufacturing issue that can damage the bottle neck in some reagent cartridges. A damaged bottle neck may cause the reagent loading process to fail when used with the Alinity i instrument. The recall affects 294 units distributed in Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia, specifically those with lot numbers 90111UI00 and 92388UI00.
The product recall record does not specify a remedy or recommended 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: 294 units Lot/code info: UDI/Lot Numbers (01)00380740121822 (17)190727(10)90111UI00 / 90111UI00 (01)00380740121822 (17)190911(10)92388UI00 / 92388UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.