Official recall record

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

US FDA — Medical Devices · 2023-09-29 · ItalyClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-09-29
Country of alert: Italy
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00380740010928
Brand on record: Sentinel CH SpA

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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