Siemens Healthcare Diagnostics, Inc. Recall 92800
Description: 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
Siemens Healthcare Diagnostics, Inc. Recall 92800 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2474-2023 |
| Event ID | 92800 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam |
| Quantity | 18524 units |
| Recall 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) |
| Device Classification | 20230906 |
| Device Code Info | Unique Device Identification (UDI): 00630414610832 All lot numbers |
| Center Classification Date | 20230828 |
| Recall Initiation Date | 20230710 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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