IRON assay — Class II medical device recall Z-0325-2024
Ongoing recall by Sentinel CH SpA, reported 2023-11-29, distributed nationwide. A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positiv
| Recall number | Z-0325-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SpA, Milan, N/A, Italy |
| Recall initiated | 2023-09-29 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 4,394 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00380740010911, 00380740010928 |
| Lot numbers | 21058Y600, 21101Y600, 30610Y600, 30918Y600 |
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0325-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.