The Recall Desk

Hazard

Incorrect Diagnosis recalls

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

What the numbers show

Total
31
Critical
0
Severe
4
Most recent
2021-08-18

Of the 31 incorrect 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 4 (13%) 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 incorrect 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 31

  • HighFDA (Devices)·Z-2258-2021·2021-08-18

    ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.

    Product
    ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2758-2020·2020-08-12

    Siemens Ysio Max X-Ray System Recalled for Software Defects

    Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2020·2020-08-12

    Siemens Luminos Agile Max Recalled for Software Collision and Image Errors

    Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2020·2020-08-12

    Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors

    Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2257-2020·2020-06-10

    Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification

    Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.

    Product
    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1991-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2020·2020-05-20

    Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.

    Product
    Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2020·2020-05-20

    Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures

    FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.

    Product
    Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2020·2020-05-20

    Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures

    Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2020·2020-05-20

    FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures

    FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead to incorrect patient diagnoses.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2020·2020-05-20

    Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy

    FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient diagnosis.

    Product
    Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2020·2020-05-20

    Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy

    FDA is recalling specific Dover Foley catheters because their temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.

    Product
    Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2019·2019-08-14

    Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits

    Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.

    Product
    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Nu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1354-2019·2019-05-22

    Abbott Alinity i Estradiol Reagent Kit Recalled for False Results

    Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.

    Product
    Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2019·2019-02-13

    GE Healthcare Recalls Centricity Universal Viewer Breast Imaging Software

    GE Healthcare is recalling Centricity Universal Viewer Breast Imaging software because a display error could lead to incorrect patient diagnoses.

    Product
    GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2927-2018·2018-09-05

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2929-2018·2018-09-05

    Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tota
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2930-2018·2018-09-05

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2018·2018-09-05

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2017·2017-07-12

    Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation

    Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.

    Product
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2017·2016-12-07

    Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results

    Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.

    Product
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2017·2016-11-16

    Roche COBAS INTEGRA c111 Analyzer Recall for Software Error

    Roche is recalling 139 COBAS INTEGRA c111 analyzers due to a software error that may cause erroneous test results.

    Product
    Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2016·2016-05-11

    Ab Sciex Analyst MD Software Recall for Incorrect Diagnostic Results

    Ab Sciex is recalling Analyst MD software versions 1.6.1 and 1.6.2 because it may display wrong quantitative results, potentially leading to incorrect patient diagnoses.

    Product
    Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2016·2015-12-16

    Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization

    Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.

    Product
    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    2 states