medical Class II Updated 2019-01-02

Abbott Ireland Diagnostics Division recalls Alinity i TSH Reagent Kit, List Number 07P4830

Recalled Product

Alinity i TSH Reagent Kit, List Number 07P4830

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)00380740131159 (17)190710(10)90061UI00 / 90061UI00 (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00 (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00
View official government recall

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