The Recall Desk

FDA (Devices) recall action 92800

Siemens Healthcare Diagnostics, Inc. recalled 4 products on 2023-09-06

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2023-09-06
Critical
0
Units
94,949

Why these products were recalled

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)

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)

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)

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2023-09-06

    Laboratory diagnostic test may produce inaccurate results from reagent carryover

    Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-06

    Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue

    Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-06

    Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results

    Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-06

    Diagnostic reagent kit recall: potential test result inaccuracy

    Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.

    Product
    Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
    Category
    Distribution
    0 states