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Recall Observatory FDA recall evidence

Device product

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

Z-2471-2023

July 10, 2023

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 92800
Status
Ongoing
Classification
Class II
Quantity
50148 units
Official record key
device-enforcement:Z-2471-2023

Official wording

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)

Code information: Unique Device Identification (UDI): 00630414595818 All Lot Numbers

Distribution pattern: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)