FDA Device recall Z-1498-2022
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) p…
- FDA Device
- Class II
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) p… by Siemens Healthcare Diagnostics, citing falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately af….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1498-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-28 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Reason
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Identifiers
| code_info | Unique Device Identification (UDI): 00630414596402 All lots |
|---|
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-1498-2022%22
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