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Abbott Ireland Diagnostics Division recalls Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle
Recalled August 14, 2019 · FDA recall Z-2208-2019 · 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
216 units
Sold at
US Distribution to states of: AR, FL, GA, MD, OK and 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 Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Manufacturer(s)
Abbott Ireland Diagnostics Division
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →