Abbott Ireland Diagnostics Division recalls Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle im…

Recall date

November 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2208-2019

FDA classification

Class II

Brand / firm

Abbott Ireland Diagnostics Division

Sold / distributed

US Distribution to states of: AR, FL, GA, MD, OK and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.