The Recall Desk

Hazard

Delayed Diagnosis recalls

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

What the numbers show

Total
57
Critical
0
Severe
2
Most recent
2026-08-12

Of the 57 delayed diagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) 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 delayed diagnosis 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.

51–57 of 57

  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2016·2016-04-27

    Siemens SOMATOM Definition CT Systems Recalled for Software Bugs

    Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, or accidental radiation.

    Product
    Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2015·2015-05-27

    Roche Homocysteine Test System Recalled for Inaccurate Low Results

    Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.

    Product
    Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2015·2015-02-11

    SCC Soft Computer Recalls SoftLab Laboratory Information System Versions

    SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.

    Product
    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2014·2014-09-24

    Becton Dickinson Recalls Vancomycin Screen Agar Due to False Resistance Results

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the product may allow susceptible bacteria to grow, leading to false resistance test results.

    Product
    BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1727-2013·2013-07-24

    Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims

    Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.

    Product
    B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring an
    Category
    Medical Device
    Distribution
    Distributed nationwide