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.

51–75 of 97

  • SevereFDA (Devices)·Z-0717-2022·2022-03-16

    Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.

    Product
    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2022·2022-02-09

    HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage

    HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.

    Product
    HARDY DIAGNOSTICS CatScreen, 25dsk/vial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2022·2022-01-05

    FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation

    Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.

    Product
    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0330-2022·2021-12-08

    Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

    Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

    Product
    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2022·2021-11-10

    Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements

    Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.

    Product
    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2022·2021-10-27

    Anti-Xa Assay On-Board Stability Reduced from 7 to 5 Days

    The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.

    Product
    HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2022·2021-10-27

    GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices

    GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.

    Product
    SIGNA Voyager nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0134-2022·2021-10-27

    GE SIGNA Pioneer MRI Recall for Missing Image Slices

    GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.

    Product
    SIGNA Pioneer nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0032-2022·2021-10-13

    Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

    Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

    Product
    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2498-2021·2021-09-29

    cobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results

    Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.

    Product
    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2021·2021-09-15

    Medical Device Test Kit Requires More Frequent Calibration Than Labeled

    Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2021·2021-09-08

    COVID-19 Antibody Test Kit Recalled for Failing Validation Requirements

    Thera Test Laboratories is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits distributed across six states because they failed to meet FDA's updated validation requirements for accurately detecting COVID-19 antibodies.

    Product
    EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2021·2021-09-08

    Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution

    Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2021·2021-08-25

    Cytocell DNA Diagnostic Probe Recalled for Unexpected Chromosomal Signals

    Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.

    Product
    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2021·2021-08-11

    Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results

    Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.

    Product
    REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2021·2021-07-14

    Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect

    Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.

    Product
    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2021·2021-07-14

    FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

    Product
    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-1953-2021·2021-07-07

    Blood Lead Test Kit Recalled for Inaccurate Control Test Results

    Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.

    Product
    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2021·2021-06-23

    Atellica CH 930 Analyzer photometer lamp may produce inaccurate results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.

    Product
    Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0880-2021·2021-01-27

    Abbott i-STAT CG8+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2021·2020-12-30

    Siemens ADVIA GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.

    Product
    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0722-2021·2020-12-30

    Siemens Atellica GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.

    Product
    Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2020·2020-07-01

    Siemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrators due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    Atellica CH Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2020·2020-04-29

    CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias

    CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.

    Product
    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
    Category
    Medical Device
    Distribution
    5 states