The Recall Desk

Hazard

Test Imprecision 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
2026-05-06

Of the 3 test imprecision 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 imprecision 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

  • ModerateFDA (Devices)·Z-1980-2026·2026-05-06

    Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results

    Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.

    Product
    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2023·2023-01-18

    IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues

    Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.

    Product
    IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KT
    Category
    Medical Device
    Distribution
    Distributed nationwide