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.

101–125 of 160

  • HighFDA (Devices)·Z-0285-2019·2018-11-07

    Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.

    Product
    Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn s
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1529-2018·2018-05-02

    Accelerate PhenoTest BC kit recalled for false positive results

    Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.

    Product
    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-1419-2018·2018-04-25

    OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results

    OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.

    Product
    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1070-2018·2018-03-21

    Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results

    Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.

    Product
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1062-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.

    Product
    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0929-2018·2018-03-14

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives

    Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.

    Product
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2018·2018-02-21

    Gibson Laboratories Recalls Blastomyces Antiserum Due to False Positives

    Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.

    Product
    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0306-2018·2018-01-10

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation

    Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.

    Product
    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1801-2017·2017-04-19

    BioMerieux Recalls VIDAS Estradiol II Assay Due to Fulvestrant Cross-Reactivity

    BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.

    Product
    VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of tota
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2017·2017-03-15

    Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference

    Siemens is recalling IMMULITE Progesterone test kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2017·2017-03-15

    Siemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results

    Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2017·2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2017·2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2017·2017-02-08

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives

    Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2017·2017-01-25

    Great Basin Staph ID/R Blood Culture Panel Recalled for False Positives

    Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.

    Product
    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2017·2016-12-28

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.

    Product
    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2016·2016-08-17

    Ortho VITROS Estradiol Reagent Recall Due to Fulvestrant Cross-Reactivity

    Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.

    Product
    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2016·2016-06-08

    Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference

    Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.

    Product
    The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1274-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors

    Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide