Alinity i TSH Reagent Kit, List Number 07P4830
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division has recalled certain Alinity i TSH Reagent Kits due to a manufacturing issue that damages bottle necks on some reagent cartridges. When a bottle neck is damaged, it can cause the reagent loading process to fail on the Alinity i instrument. A total of 678 units across specific lot numbers were distributed to Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia.
The recall affects reagent kits with the following lot/code information: UDI/Lot Numbers (01)00380740131159 (17)190710(10)90061UI00 / 90061UI00, (01)00380740131159 (17)190827(10)91526UI00 / 91526UI00, and (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00. The source does not specify a remedy or recommended consumer action.
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: 678 units Lot/code info: UDI/Lot Numbers: (01)00380740131159 (17)190710(10)90061UI00 / 90061UI00 (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00 (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.