The Recall Desk

Hazard

Diagnostic Accuracy Risk recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2025-02-05

Of the 6 diagnostic accuracy risk 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 diagnostic accuracy risk 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.

1–6 of 6

  • HighFDA (Devices)·Z-1020-2025·2025-02-05

    HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures

    Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.

    Product
    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0615-2025·2024-12-11

    GE Healthcare CT Operator Console Update: Images May Rotate Progressively

    GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0892-2022·2022-04-13

    Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance

    WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.

    Product
    First SIGN SARS-CoV-2 Antigen Test
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0082-2022·2021-10-20

    Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

    Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

    Product
    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2021·2021-07-14

    ACE Control Set stability claim failure requires updated handling instructions

    Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.

    Product
    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2021·2021-06-09

    Change Healthcare Enterprise Viewer software defect affects image display settings

    A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.

    Product
    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
    Category
    Medical Device
    Distribution
    Distributed nationwide