The Recall Desk

Hazard

False Positive recalls

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

What the numbers show

Total
160
Critical
3
Severe
10
Most recent
2026-09-02

Of the 160 false positive recalls we have scored against our rubric, 3 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (6%) 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 false positive 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 160

  • HighFDA (Devices)·Z-0407-2024·2023-12-06

    Abbott Alinity m HCV Kit Recalled for False Positive Results

    Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.

    Product
    Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in hum
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0357-2024·2023-11-29

    Medical Device Cartridges Recalled for Blood Oxygen Reading Errors

    Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0219-2024·2023-11-15

    Blood Lead Test Kits Recalled for Defective Treatment Reagent Caps

    Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.

    Product
    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2023·2023-05-31

    Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly

    Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.

    Product
    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1350-2023·2023-04-19

    First Response Easy Read App unable to reliably read pregnancy test results

    Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.

    Product
    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2023·2023-03-01

    Hepatitis B Diagnostic Test Kits Recalled for Test Interference

    Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.

    Product
    ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2023·2023-01-11

    Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips

    Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.

    Product
    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0718-2023·2022-12-21

    Siemens allergy test kits recalled for false mold allergen reactivity results

    Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2023·2022-12-07

    CMV IgM EIA Diagnostic Test Recalled for Increased False Positives

    Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.

    Product
    CMV IgM EIA, in vitro diagnostic.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0097-2023·2022-10-26

    Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies

    Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Product
    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1651-2022·2022-09-07

    therascreen FGFR RGQ Kit Recalled for Increased False Positive Results

    Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.

    Product
    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1652-2022·2022-09-07

    RT-PCR Kit Recalled Due to False Positive Test Results

    Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.

    Product
    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1340-2022·2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2022·2022-05-18

    FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk

    Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.

    Product
    Accula SARS-CoV-2 Test, REF: COV4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2022·2022-05-18

    ProterixBio SARS-CoV-2 Antibody Test Recalled for Inaccurate Results

    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test kits are being recalled due to insufficient clinical performance data. The FDA determined test results may not be accurate, with potential false positives or false negatives.

    Product
    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1000-2022·2022-05-04

    NeuMoDx COVID-19 test cartridges recalled for false positive risk

    NeuMoDx Molecular is recalling diagnostic cartridges used in COVID-19 and flu/RSV tests because of potential for false positive SARS-CoV-2 results, which could lead to incorrect patient management.

    Product
    NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2022·2022-04-27

    Genetic Testing Kit Recalled for Inaccurate Mutation Test Results

    Qiagen Sciences' KRAS mutation testing kit can produce false positive or false negative results due to testing flags or warnings. 435 kits distributed across 16 U.S. states are affected.

    Product
    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0945-2022·2022-04-27

    Acon Biotech Flowflex COVID-19 Rapid Test Recalled for Inaccurate Results

    Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.

    Product
    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0883-2022·2022-04-13

    Abbott Alinity m HBV Device Misquantitation of Negative Samples

    Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

    Product
    Alinity m HBV Application Specification File (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0884-2022·2022-04-13

    Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results

    Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.

    Product
    Alinity m HBV AMP Kit (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0828-2022·2022-04-06

    Cobas Liat respiratory virus analyzer units recalled for false Influenza B results

    Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.

    Product
    cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2022·2022-03-16

    FDA Recalls Diagnostic Test Strips for False Positive Results

    NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2022·2022-03-09

    COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results

    Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0704-2022·2022-03-09

    Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing

    A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.

    Product
    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2022·2022-02-09

    Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity

    Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.

    Product
    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
    Category
    Medical Device
    Distribution
    Distributed nationwide