The Recall Desk

Hazard

Inaccurate Diagnosis recalls

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

What the numbers show

Total
30
Critical
1
Severe
2
Most recent
2026-09-02

Of the 30 inaccurate diagnosis recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (7%) 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 inaccurate 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.

26–30 of 30

  • HighFDA (Devices)·Z-1881-2013·2013-08-14

    Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.

    Product
    ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2013·2013-01-23

    Perkinelmer Recalls NEOBASE MSMS Kits Due to Defective Microplate Wells

    Perkinelmer is recalling NEOBASE Non-Derivatized MSMS Kits because the microplate wells used in the assays are defective. This may affect the accuracy of newborn metabolic disorder screening.

    Product
    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2012·2012-08-15

    Abbott i-Stat BNP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.

    Product
    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2171-2012·2012-08-15

    Abbott i-Stat CK-MP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.

    Product
    i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myo
    Category
    Medical Device
    Distribution
    3 states