The Recall Desk

Hazard

Delayed Diagnosis recalls

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

What the numbers show

Total
57
Critical
0
Severe
2
Most recent
2026-08-12

Of the 57 delayed 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 2 (4%) 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 delayed 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.

26–50 of 57

  • HighFDA (Devices)·Z-0425-2022·2022-01-05

    VIDAS diagnostic test for C. difficile recalled due to substrate defect

    bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.

    Product
    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2022·2021-12-01

    Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

    Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

    Product
    SOMATOM Confidence with software syngo.CT VB20 Model #10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2021·2021-04-14

    Becton Dickinson Recalls Martin-Lewis Agar Due to Fungal Growth

    Becton Dickinson is recalling Martin-Lewis Agar plates because they show heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2021·2021-04-14

    BD BBL Martin-Lewis Agar Recalled for Misformulation and Fungal Growth

    Becton Dickinson is recalling BD BBL Martin-Lewis Agar due to misformulation causing heavy fungal growth, which may delay the diagnosis of Neisseria infections.

    Product
    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2021·2021-03-24

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.

    Product
    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0771-2021·2021-01-20

    Siemens SOMATOM CT Scanner Software Recall for Scan Parameter Issues

    Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.

    Product
    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2020·2020-08-12

    BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results

    Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.

    Product
    BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasophar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2020·2020-06-17

    Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure

    Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.

    Product
    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1426-2020·2020-03-11

    Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1425-2020·2020-03-11

    Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk

    Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.

    Product
    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1424-2020·2020-03-11

    Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1423-2020·2020-03-11

    Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference

    Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1422-2020·2020-03-11

    Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference

    Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.

    Product
    Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-2440-2019·2019-09-11

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling syngo.CT software version VA48A_SP5.5 for specific SOMATOM CT models due to scanning workflow interruptions and unexpected user notifications.

    Product
    syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2019·2018-12-26

    Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction

    Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.

    Product
    AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0599-2019·2018-12-19

    Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage

    Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.

    Product
    AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2019·2018-12-05

    Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure

    Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2019·2018-11-28

    Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect

    Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.

    Product
    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2019·2018-11-21

    Tosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction

    Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.

    Product
    AIA-900 Analyzer, Product code 022930, 022930R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2018·2018-05-16

    Inpeco Laboratory Automation Systems Recalled for Module Freezing Risk

    Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1470-2017·2017-03-22

    Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors

    Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.

    Product
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2017·2017-02-15

    Merge PACS Software Recalled for Potential Incorrect Patient Image Display

    Merge Healthcare is recalling Merge PACS software version 7.0.1 because it may display incorrect patient images, potentially delaying diagnosis or treatment.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1180-2017·2017-02-15

    Merge RadSuite software recalled due to incorrect pixel value data

    Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.

    Product
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0878-2017·2016-12-28

    Merge OrthoCase software recall due to measurement errors

    Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.

    Product
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    15 states