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.

126–150 of 160

  • ModerateFDA (Devices)·Z-1272-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.

    Product
    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2016·2016-04-06

    Roche Estradiol III Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche is recalling the Estradiol III assay because fulvestrant treatment causes falsely elevated estradiol results, potentially leading to incorrect patient management.

    Product
    Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2016·2016-04-06

    Roche Estradiol II Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche Diagnostics is recalling the Elecsys Estradiol II assay because fulvestrant treatment causes falsely elevated estradiol results.

    Product
    Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivativ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2016·2016-02-03

    Phadia Recalls EliA SmDP Wells Due to Invalid Test Results

    Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.

    Product
    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2015·2015-08-26

    Veridex Recalls Cell Search Circulating Tumor Kits Due to Artifacts

    Veridex, LLC is recalling 1,560 Cell Search Circulating Tumor Kits due to the presence of artifacts and control failures.

    Product
    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2015·2015-07-08

    BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall

    BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.

    Product
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2015·2015-07-01

    Remel VersaTREK Instrument Series 528 Recalled for False Positive Reports

    Remel Inc. is recalling 21 VersaTREK Instrument Series 528 devices because their use may result in false positive reports.

    Product
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2015·2015-07-01

    Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports

    Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.

    Product
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2015·2015-02-11

    Express Diagnostics Recalls DrugCheck Ketamine Dip Tests for False Positives

    Express Diagnostics is recalling DrugCheck Ketamine Dip Tests because they may produce false positive results, leading to incorrect screening outcomes.

    Product
    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0467-2015·2014-12-03

    Biomerica Recalls Calcitonin ELISA Kits Due to Potential False High Values

    Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.

    Product
    Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0102-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2014·2014-09-17

    BD MAX MRSA Assay Recalled for False Positive Results

    Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.

    Product
    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2138-2014·2014-08-13

    Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure

    Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.

    Product
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1672-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminesc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2014·2014-03-12

    Focus Diagnostics Recalls Simplexa Flu and RSV Assay Kits

    Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.

    Product
    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2014·2014-02-05

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic results.

    Product
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and resp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2123-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall

    Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2124-2013·2013-09-18

    Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2120-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2013·2013-08-28

    Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits

    Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.

    Product
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1272-2013·2013-05-15

    Siemens MicroScan MICroSTREP panels recalled for false susceptibility results

    Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.

    Product
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2013·2013-05-15

    Becton Dickinson Recalls Gonorrhea Test Kits Due to False Positives

    Becton Dickinson is recalling 77 BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assay Reagent Packs due to increased levels of false positives.

    Product
    BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson a
    Category
    Medical Device
    Distribution
    5 states