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.

1–25 of 30

  • HighFDA (Devices)·Z-3013-2026·2026-09-02

    Midmark Digital ECG Software Recall for Incorrect Waveform Display

    Midmark is recalling Digital ECG HD+12 and HD+15 units with specific IQecg plugin software versions due to a communication anomaly that may cause incorrect ECG waveforms and inaccurate heart rate calculations.

    Product
    Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2976-2026·2026-08-26

    Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.

    Product
    Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2975-2026·2026-08-26

    Siemens Quinidine Assay Recalled for Precision Errors

    Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.

    Product
    Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2026·2026-05-13

    BioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives

    BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.

    Product
    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2023·2022-12-21

    Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results

    Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2021·2021-02-24

    Confirm Biosciences Recalls Healgen COVID-19 Rapid Test Cassettes

    Confirm Biosciences is recalling Healgen COVID-19 Rapid Test Cassettes because they were distributed to non-certified labs and not validated for fingerstick use.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from antic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3037-2020·2020-10-07

    Ameditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance

    Ameditech Inc is recalling 23,000 MicroScreen immunoassay units because they failed to consistently detect compounds at labeled levels.

    Product
    MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2020·2020-10-07

    Ameditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures

    Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.

    Product
    First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3046-2020·2020-10-07

    Ameditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures

    Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2018·2018-03-21

    Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation

    Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.

    Product
    ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraopera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2017·2017-05-24

    Magellan LeadCare Blood Analyzer Recall for Falsely Low Lead Results

    Magellan Diagnostics is recalling LeadCare Ultra Blood Analyzers because they may generate falsely low lead concentrations when used with specific Becton Dickinson collection tubes.

    Product
    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2016·2016-07-27

    Carestream Touch Ultrasound Recalled for Volume Measurement Software Error

    Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.

    Product
    Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0313-2016·2015-11-25

    Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups

    Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.

    Product
    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2016·2015-11-25

    Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests

    Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.

    Product
    DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling specific software versions for its s5 and CORE Intravascular Ultrasound Systems because they may calculate inaccurate FFR/iFR values under certain circumstances.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2014·2014-04-02

    Abbott i-STAT G3+ Cartridge Recall for Inaccurate Blood Gas Results

    Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.

    Product
    i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2014·2014-03-26

    Alere Triage TOX Drug Screen Recalled for False Negative PCP Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.

    Product
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Tri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2014·2014-03-05

    Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results

    Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.

    Product
    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2014·2014-01-15

    Siemens HbA1c Flex Reagent Cartridge Recall for Positive Bias

    Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.

    Product
    HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2013·2013-09-18

    Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error

    Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.

    Product
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1897-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide