The Recall Desk

Hazard

Diagnostic Delay recalls

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

What the numbers show

Total
54
Critical
0
Severe
0
Most recent
2025-07-23

Of the 54 diagnostic delay recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 diagnostic delay 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.

26–50 of 54

  • HighFDA (Devices)·Z-0719-2024·2024-01-24

    Incisive CT systems with ECG cable risk of signal loss

    Philips Incisive CT systems with specific ECG cable may experience signal loss due to connector weakness, potentially delaying diagnosis.

    Product
    Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0733-2024·2024-01-24

    VACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive

    VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.

    Product
    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2024·2023-12-20

    Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays

    The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.

    Product
    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2024·2023-12-20

    Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results

    Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.

    Product
    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2023·2023-04-26

    Laboratory diagnostic device software issue may delay clinical diagnosis

    BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.

    Product
    BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2023·2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2023·2022-12-28

    GE Centricity Universal Viewer 6.0 Medical Imaging Software May Hide Studies

    GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.

    Product
    Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2022·2022-04-27

    CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation

    Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.

    Product
    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2022·2022-01-05

    VIDAS Lyme diagnostic test device recalled due to substrate error

    bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

    Product
    VIDAS Lyme IgG II (LYM), REF 417401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0310-2022·2021-12-08

    Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls

    DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.

    Product
    Total Thyroxine (T4) ELISA; REF EIA-1781
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2022·2021-12-01

    CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays

    Siemens SOMATOM Definition Flash CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnoses and require additional rescans and contrast media. This recall affects 121 units distributed nationwide.

    Product
    SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2022·2021-12-01

    Siemens CT Scanner Software May Cause Diagnostic Workflow Delays

    Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.

    Product
    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0284-2022·2021-12-01

    CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays

    A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.

    Product
    SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2021·2021-09-29

    Siemens CT Scanners: Software Errors May Interrupt Scanning Workflows

    Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.

    Product
    Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2021·2021-08-25

    Cell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling

    Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.

    Product
    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3025-2020·2020-10-07

    Siemens CT Software Recall for Workflow Interruptions and Diagnostic Delays

    Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.

    Product
    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confiden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2536-2020·2020-07-15

    Capso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure

    Capso Vision is recalling 82 CapsoCam Plus capsules because they fail to record data when ingested, potentially delaying diagnosis.

    Product
    The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2019·2019-07-10

    Siemens SOMATOM go.All CT Systems Recalled for Performance Issues

    Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.

    Product
    SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2019·2019-07-10

    Siemens SOMATOM go.Up CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Up CT systems due to sporadic performance problems that may cause diagnostic delays or patient rescans.

    Product
    SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The image
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2019·2019-07-10

    Siemens SOMATOM go.Up CT Scanner Recalled for Performance Issues

    Siemens Medical Solutions is recalling nine SOMATOM go.Up CT scanners due to sporadic performance problems that may interrupt scanning workflows and delay patient diagnosis.

    Product
    SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images deli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2019·2019-07-10

    Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues

    Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient diagnoses.

    Product
    SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2019·2019-07-10

    Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2019·2019-07-10

    Siemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling 53 SOMATOM go.Now CT scanners due to potential sporadic performance problems that may cause scanning workflow interruptions and delays in diagnosis.

    Product
    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2019·2019-07-10

    Siemens SOMATOM go.All CT Scanner Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.

    Product
    SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
    Category
    Medical Device
    Distribution
    Distributed nationwide