medical Class II Updated 2019-01-02

Abbott Ireland Diagnostics Division recalls Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

Recalled Product

Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121


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)00380740160616 (17)190807(10)92056UI00 / 92056UI00
View official government recall

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