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

Recall date

November 21, 2018

Source

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

Recall number

Z-0666-2019

FDA classification

Class II

Brand / firm

Abbott Ireland Diagnostics Division

Sold / distributed

AR, FL, GA, MD, OK, 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 Total Beta-hCG Reagent Kit, List Number 07P5121