Sentinel CH SpA recalls IRON assay, Reference Numbers 6K95-41 and 6K95-30

Recall date

September 29, 2023

Source

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

Recall number

Z-0325-2024

FDA classification

Class II

Brand / firm

Sentinel CH SpA

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

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

What was recalled

IRON assay, Reference Numbers 6K95-41 and 6K95-30