Class II — Sentinel CH SpA
| Recalling firm | SENTINEL CH. SpA |
|---|---|
| Registered facility | SENTINEL CH. SPA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Alinity c Iron Reagent, Reference Number 08P3920 |
| Quantity | 4400 kits |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2023-09-29 |
| Classified | 2023-11-17 |
| Recall number | Z-0326-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sentinel CH SpA (Z-0326-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93298/
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