medical Class II Updated 2019-01-02

Abbott Ireland Diagnostics Division recalls Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532

Recalled Product

Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532


Hazard / Issue

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.

Issued by

FDA

Affected States: AR, FL, GA, MD, OK, VA
Lot/Code Info: UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00
View official government recall

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