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Recall Observatory FDA recall evidence

Device product

Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

Z-2474-2023

July 10, 2023

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 92800
Status
Ongoing
Classification
Class II
Quantity
18524 units
Official record key
device-enforcement:Z-2474-2023

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): 00630414610832 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)