Total immunoglobulin M — Class II medical device recall Z-1003-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-02-14, distributed nationwide. Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH
| Recall number | Z-1003-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CW, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LV, MA, MX, NL, NO, NZ, OM, PE, PK, PL, PT, PY, RO, RS, SA, SE, SG, SK, TR, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00630414595627 |
| Lot numbers | 221764, 221829, 231915, 232025 |
Product
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Reason for recall
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1003-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.