Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the… — Class II medical device recall Z-2474-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-09-06, distributed nationwide. Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality
| Recall number | Z-2474-2023 |
|---|---|
| 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 | 2023-07-10 |
| Classified | 2023-08-28 |
| Reported by FDA | 2023-09-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW, UY, VN |
| Quantity | 18,524 units |
| UPC / GTIN / UDI-DI | 00630414610832 |
Product
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
Reason for recall
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
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-2474-2023. 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.