Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0325-2024 — IRON assay, Reference Numbers 6K95-41 and 6K95-30

U.S. FDA — Device Enforcement · Italy · 2023-09-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0325-2024
Date of alert
2023-09-29
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Sentinel CH SpA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380740010928
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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