Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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) |
| Product | Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214 |
| Quantity | 6733 units |
| Distribution | US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam |
| Initiated | 2023-07-10 |
| Classified | 2023-08-28 |
| Recall number | Z-2472-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-2472-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92800/
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