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.

76–100 of 160

  • ModerateFDA (Devices)·Z-2301-2020·2020-06-17

    Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination

    Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test results.

    Product
    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2020·2020-06-03

    Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error

    The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.

    Product
    Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2163-2020·2020-06-03

    Hologic Panther Fusion Extraction Reagent-S Recalled for False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.

    Product
    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2048-2020·2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2020·2020-05-20

    BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions

    Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.

    Product
    Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2020·2020-05-06

    Beckman Coulter Recalls Barbiturates Reagent Due to Potential Test Inaccuracy

    Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative results.

    Product
    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbitura
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2020·2020-04-29

    Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues

    Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.

    Product
    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1751-2020·2020-04-29

    Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity

    Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.

    Product
    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1552-2020·2020-04-01

    Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error

    Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.

    Product
    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0119-2020·2019-10-16

    Horiba ABX Pentra Lipase CP Analyzer Recall for Interference

    Horiba Instruments is recalling ABX Pentra Lipase CP analyzers because triglyceride and cholesterol interference may cause false abnormal lipase results.

    Product
    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2552-2019·2019-10-02

    Sentinel CH SpA Recalls Alinity c Lithium Reagent Kits

    Sentinel CH SpA is recalling Alinity c Lithium Reagent Kits due to a potential carryover issue that may result in falsely elevated lithium patient results.

    Product
    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2019·2019-08-14

    Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits

    Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.

    Product
    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Nu
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2134-2019·2019-08-07

    Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits

    Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.

    Product
    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determina
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2082-2019·2019-07-31

    Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts

    Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.

    Product
    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2019·2019-05-22

    BD Veritor System Reader Recalled for Potential False Test Results

    Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that may cause false positive or negative test results.

    Product
    BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1296-2019·2019-05-15

    Abbott ARCHITECT cSystems ICT Module Recall for False Chloride Results

    Abbott is recalling ARCHITECT cSystems ICT Modules due to a potential for falsely elevated serum or plasma chloride results.

    Product
    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2019·2019-04-24

    bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results

    bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.

    Product
    Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0847-2019·2019-02-27

    bioMerieux Recalls VITEK 2 AST-N351 Test Kits Due to False Positives

    bioMerieux, Inc. is recalling VITEK 2 AST-N351 Test Kits distributed in the UK and Ireland because they may produce false positive results for ESBL phenotypes.

    Product
    VITEK 2 AST-N351 Test Kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0493-2019·2018-11-28

    BD Urine Collection Cups May Elevate Red Blood Cell Counts

    Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0492-2019·2018-11-28

    BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.

    Product
    BD Vacutainer Specimen Collection Cups, Cat. No. 364975
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0446-2019·2018-11-21

    BioFire FilmArray Meningitis/Encephalitis Panel Recalled for False Positive Risk

    BioFire Diagnostics is recalling specific FilmArray Meningitis/Encephalitis (ME) Panel kits due to a manufacturing issue that may cause elevated rates of false positive results for HSV-1.

    Product
    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2019·2018-11-07

    BD Max Instrument Reader Spare Part Recalled for False Positive Results

    Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.

    Product
    BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2019·2018-11-07

    BD Max Instrument Recall for False Positive Candida Results

    Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.

    Product
    BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The
    Category
    Medical Device
    Distribution
    Distributed nationwide