The Recall Desk

Hazard

Diagnostic Error recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all diagnostic error 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.

51–75 of 170

  • HighFDA (Devices)·Z-0611-2025·2024-12-11

    GE Healthcare CT System May Produce Rotated Diagnostic Images

    GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.

    Product
    GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2025·2024-12-11

    CT imaging systems may display progressively rotated images in certain scan modes

    Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.

    Product
    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0616-2025·2024-12-11

    GE Healthcare CT Scanner Console Images May Rotate After First Scan

    Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0535-2025·2024-12-04

    VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results

    Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.

    Product
    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2025·2024-10-23

    Access TSH assay reagent packs may produce erroneously low results

    Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.

    Product
    The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2025·2024-10-16

    Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

    The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

    Product
    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2024·2024-10-02

    BD Phoenix diagnostic systems may misidentify E. coli in clinical samples

    The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.

    Product
    BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2024·2024-09-04

    Lab analyzer incorrectly configured for complex testing at waived facilities

    Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.

    Product
    Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2024·2024-08-28

    VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results

    Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.

    Product
    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2024·2024-08-21

    Dental X-Ray Device Testing Defect May Affect Image Repeatability

    Palodex Group Oy recalls the Orthopantomograph OP300 dental x-ray system due to a testing software defect that may allow devices with poor image repeatability to be distributed.

    Product
    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2024·2024-08-21

    Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results

    Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.

    Product
    BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2514-2024·2024-08-14

    Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium

    BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2024·2024-07-31

    Beckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings

    Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.

    Product
    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2024·2024-07-24

    BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results

    BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.

    Product
    BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent wit
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2325-2024·2024-07-17

    Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug

    Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.

    Product
    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2214-2024·2024-07-03

    RAPIDPoint 500e diagnostic system mislabels capillary blood samples as arterial

    Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.

    Product
    Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.

    Product
    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2024·2024-05-29

    Thyroid Autoantibody Test System Recalled for Falsely Elevated Results

    Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2024·2024-05-22

    VITROS Free T3 Calibrators recalled due to positive bias in thyroid test results

    QUIDELORTHO is recalling VITROS Free T3 Calibrators used in thyroid testing because they may produce elevated results that could lead to incorrect patient diagnosis or delayed care.

    Product
    VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2024·2024-05-22

    Free T3 Reagent Pack May Produce Inaccurate Test Results

    QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2024·2024-05-01

    Tissue Processor Recall: HistoCore PEGASUS May Produce Damaged Specimens

    Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.

    Product
    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2024·2024-05-01

    Diagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export

    ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.

    Product
    ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2024·2024-04-10

    BD Phoenix diagnostic panel recalled for drug cross-contamination

    Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.

    Product
    BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2024·2024-03-27

    Siemens DCA HbA1c Reagent Kit Recalled for Inaccurate Test Results

    Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.

    Product
    DCA Systems HbA1c Reagent Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide