medical Class II Updated 2019-01-02

Abbott Ireland Diagnostics Division recalls Alinity i Progesterone Reagent Kit, List Number 08P3620

Recalled Product

Alinity i Progesterone Reagent Kit, List Number 08P3620


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)00380740121877 (17)190503(10) 91254UI00 / 91254UI00 (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00
View official government recall

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