FDA Device recall Z-2666-2023
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) by Siemens Healthcare Diagnostics, citing there is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2666-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-08 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Reason
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
Identifiers
| code_info | (6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821 |
|---|
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-2666-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.