Home / Recalls / Medical Devices
Abbott Ireland Diagnostics Division recalls Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Recalled January 2, 2019 · FDA recall Z-0669-2019 · Abbott Ireland Diagnostics Division
Hazard
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. · FDA Class II
Units
760 units
Sold at
AR, FL, GA, MD, OK, VA
Description
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.
Product
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Manufacturer(s)
Abbott Ireland Diagnostics Division
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →