Siemens Healthcare Diagnostics, Inc.: Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium

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: 19544 units Lot/code info: Unique Device Identification (UDI): 00630414596440 All Lot Numbers

UPC codes

00630414596440

Source

Official record: FDA (Device enforcement) ↗

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