FDA Device recall Z-2474-2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithi…
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithi… by Siemens Healthcare Diagnostics, citing 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 Atell….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2474-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-10 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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)
Identifiers
| code_info | Unique Device Identification (UDI): 00630414610832 All lot numbers |
|---|
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-2474-2023%22
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