Hazard

Misdiagnosis recalls

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

What the numbers show

Total: 94
Critical: 0
Severe: 7
Most recent: 2026-08-12

Of the 94 misdiagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (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 misdiagnosis 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.

76–94 of 94

HighFDA (Devices)·Z-0816-2015·2014-12-24
Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations
Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.
Product
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0815-2015·2014-12-24
Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations
Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.
Product
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0818-2015·2014-12-24
Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements
Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.
Product
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-2535-2014·2014-08-27
Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers
Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.
Product
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1476-2014·2014-04-30
BioMerieux Recalls FB Reagent Due to False Negative Test Results
BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.
Product
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1216-2014·2014-03-26
Siemens syngo Dynamics PACS Recalled for Potential Patient Data Mixup
Siemens is recalling 50 syngo Dynamics PACS units because improper error handling could display images for one patient and reports for another, risking misdiagnosis.
Product
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2013·2013-05-08
Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion
Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.
Product
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1164-2013·2013-05-01
GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk
GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.
Product
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imagin
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0807-2013·2013-02-20
Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal sp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0819-2013·2013-02-20
Quidel Recalls Sofia Influenza A+B FIA Kits Due to False Positives
Quidel is voluntarily recalling specific lots of Sofia Influenza A+B FIA kits because they may produce false positive results, potentially leading to misdiagnosis.
Product
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0806-2013·2013-02-20
Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in huma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2013·2012-12-19
Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects
Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.
Product
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0116-2013·2012-10-31
Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity
Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.
Product
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for ide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0046-2013·2012-10-17
Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
Product
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2012·2012-08-15
Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results
Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.
Product
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1930-2012·2012-07-18
Alere Triage Profiler SOB Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2012·2012-07-18
Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.
Product
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2012·2012-07-11
Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect
Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.
Product
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populatio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2012·2012-07-04
Siemens B12 Reagent Cartridges Recalled for False Test Results
Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.
Product
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide