medical Class II Updated 2023-09-06

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH LDL Cholesterol- In vitro diagnostic use in the

Recalled 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


Hazard / Issue

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)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Unique Device Identification (UDI): 00630414611037 All Lot Numbers
View official government recall

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