FDA Device recall Z-1003-2024
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry by Siemens Healthcare Diagnostics, citing potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1003-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-15 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Reason
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Identifiers
| code_info | Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/…Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2024%22
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