Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Check against the official notice below — it lists the full affected range.
Abbott Ireland Diagnostics Division is recalling certain lots of Alinity i 25-OH Vitamin D Reagent Kit due to a manufacturing defect that can damage the bottle neck on some reagent cartridges. The affected lots are identified by specific UDI and lot numbers and were distributed to Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia. A total of 760 units are involved in this recall.
When a bottle neck is damaged, it may prevent the reagent from loading properly into the Alinity i instrument. The source document does not specify what consumers or healthcare facilities should do with recalled product.
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: 760 units Lot/code info: UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.