Reported Nov 29, 2023 · Ongoing
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Sentinel CH SpA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sentinel CH SpA · Via Robert Koch 2 · Milan, N/A · N/A
Is this the product you have?
- IRON assay, Reference Numbers 6K95-41 and 6K95-30
- Lot codes and dates
- Reference Number 6K95-41UDI-DI: 00380740010928
- Lot Number30610Y600
- Reference Number 6K95-30UDI-DI: 00380740010911
- Lot Numbers
21058Y60021101Y60030918Y600
- Amount recalled
- 4394 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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