The Recall Desk

Hazard

Negative Bias recalls

7 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-04-08

Of the 7 negative bias recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all negative bias recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–7 of 7

  • HighFDA (Devices)·Z-1657-2026·2026-04-08

    Atellica hemoglobin A1c assay may return depressed patient results

    Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2024·2024-07-10

    VITROS Chemistry FS Diluent Pack 3 Recalled for Negatively Biased Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2023·2023-03-01

    ADVIA Centaur Folate 500 test kits recalled for inaccurate measurement results

    Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.

    Product
    ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2022·2022-10-05

    Siemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results

    Siemens is recalling IMMULITE 2000 and XPi Thyroid Stimulating Immunoglobulins test kits due to a -23% negative bias that may produce falsely low results, potentially delaying diagnosis of autoimmune thyroid disease.

    Product
    IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2022·2022-09-07

    Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.

    Product
    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2019·2019-08-14

    Siemens Ferritin Reagent Cartridge Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.

    Product
    Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the d
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-1256-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A kits due to confirmed negative bias and potential calibration failures for the FT4 assay on certain ADVIA Centaur systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide