The Recall Desk

Hazard

Diagnostic Inaccuracy recalls

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

What the numbers show

Total
97
Critical
0
Severe
5
Most recent
2026-08-12

Of the 97 diagnostic inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) 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 inaccuracy 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 97

  • HighFDA (Devices)·Z-2888-2026·2026-08-12

    MicroScan LabPro V5.03 Panel Update 11 analyzers recalled for incorrect algorithms affecting test results

    The FDA is recalling MicroScan LabPro V5.03 Panel Update 11 electronic analyzers because their algorithms may produce inaccurate antimicrobial susceptibility test results.

    Product
    REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2026·2026-07-15

    Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias

    Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2025·2025-03-12

    TBS iNsight bone density software calculation variability on Hologic machines

    TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.

    Product
    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitom
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1004-2025·2025-01-29

    BD PCR Cartridges for MAX System signal drift in select lots

    Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

    Product
    BD PCR Cartridges used with MAX System. Model Number: 437519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2025·2024-12-04

    HPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization

    Kreatech PapV-16 HPV-16 diagnostic probes are recalled for suboptimal DNA hybridization due to oversized DNA fragments. This may cause false positives or false negatives if proper laboratory controls are not used.

    Product
    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0234-2025·2024-11-06

    Abbott STI and HPV Test Kits Recalled for Quality Control Failures

    Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.

    Product
    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3304-2024·2024-10-09

    ADVIA Centaur aTPO Assay kits recalled due to positive result bias

    Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.

    Product
    ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2024·2024-09-18

    Siemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells

    Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.

    Product
    Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3064-2024·2024-09-18

    ADVIA Chemistry urinary protein reagent quality control failure

    Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3100-2024·2024-09-18

    Medical device diagnostic test shows measurement bias in certain samples

    Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.

    Product
    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2024·2024-08-28

    Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing

    The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2024·2024-07-03

    Sight OLO CBC Test Kit Lot Recalled for Bacterial Contamination

    One lot of Sight OLO CBC Test Kit is being recalled due to bacterial contamination that causes artificially elevated platelet counts. The affected kits may produce inaccurate test results.

    Product
    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2024·2024-03-20

    ADVIA Centaur Erythropoietin Assay Affected by -35% Measurement Bias

    Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.

    Product
    ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2024·2024-02-21

    BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results

    BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2024·2024-02-14

    BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy

    BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2024·2024-01-17

    H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label

    Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.

    Product
    Detector H. Pylori, Catalog Number IHP-30
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0325-2024·2023-11-29

    IRON assay kits recalled for inaccurate diagnostic results

    Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.

    Product
    IRON assay, Reference Numbers 6K95-41 and 6K95-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2023·2023-10-11

    Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results

    Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.

    Product
    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2023·2023-07-26

    RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences

    FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.

    Product
    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2023·2023-07-05

    VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results

    Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.

    Product
    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2023·2023-05-24

    Urine Analysis Diagnostic Device Software Issue Prevents Carryover Detection

    Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.

    Product
    UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1417-2023·2023-04-26

    Philips 2D Perfusion Medical Imaging Software Recalled for Signal Processing Errors

    Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.

    Product
    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide