Z-2471-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50148 units
Product Description
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
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 Pattern
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Code Information
Unique Device Identification (UDI): 00630414595818 All Lot Numbers