FDA Device recall Z-0325-2024
IRON assay, Reference Numbers 6K95-41 and 6K95-30
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of IRON assay, Reference Numbers 6K95-41 and 6K95-30 by Sentinel Ch Spa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0325-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-29 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sentinel Ch Spa |
| Distribution | US |
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
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.
Identifiers
| code_info | Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 0038074001…Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0325-2024%22
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