The Recall Desk

Hazard

Test Bias recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-07-15

Of the 3 test 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 test 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.

1–3 of 3

  • HighFDA (Devices)·Z-2703-2026·2026-07-15

    Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias

    Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2022·2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2017·2017-06-07

    Siemens SHBG Immulite 2000 Reagent Recall Due to Stability Issues

    Siemens is recalling certain lots of SHBG Immulite 2000 reagents because they may not meet stability claims, potentially causing test bias.

    Product
    SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
    Category
    Medical Device
    Distribution
    Distributed nationwide