Siemens Healthcare Diagnostics, Inc.: Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodiu

Hazard

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)

Details from the source

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) Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam Quantity: 18524 units Lot/code info: Unique Device Identification (UDI): 00630414610832 All lot numbers

UPC codes

00630414610832

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.