The Recall Desk

Hazard

False Negative Result recalls

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

What the numbers show

Total
72
Critical
1
Severe
4
Most recent
2026-08-19

Of the 72 false negative result recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (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 negative result 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 72

  • HighFDA (Devices)·Z-0732-2019·2019-01-23

    Meridian Premier Cryptococcal Antigen Test Recalled for Stability Issues

    Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.

    Product
    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3012-2018·2018-09-26

    Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects

    Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.

    Product
    CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2999-2018·2018-09-26

    Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking

    Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2997-2018·2018-09-26

    Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3005-2018·2018-09-26

    Ventana ISH Protease 3 Reagent Recall for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3002-2018·2018-09-26

    Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks

    Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.

    Product
    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3009-2018·2018-09-26

    Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects

    Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative results.

    Product
    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3003-2018·2018-09-26

    Ventana Anti-Pan Keratin Antibody Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3004-2018·2018-09-26

    Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled

    Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3014-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

    Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.

    Product
    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3010-2018·2018-09-26

    Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks

    Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.

    Product
    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2998-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry results.

    Product
    iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2996-2018·2018-09-26

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.

    Product
    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3013-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers

    Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.

    Product
    CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3016-2018·2018-09-26

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 342 units of the ultraView SISH DNP Detection Kit because leaking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3000-2018·2018-09-26

    Ventana OptiView Amplification Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.

    Product
    OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3007-2018·2018-09-26

    Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3011-2018·2018-09-26

    Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects

    Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.

    Product
    CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3001-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.

    Product
    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1893-2018·2018-05-23

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Strips Due to Defect

    Beckman Coulter is recalling a subset of iChem VELOCITY Urine Chemistry Strips because an incorrect pad may cause false negative results for leukocytes.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2018·2018-05-02

    Life Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk

    Life Technologies is recalling 30 units of the Oncomine Dx Target Test because a lower RNA concentration could cause false negative results for ROS1 fusion, potentially affecting patient treatment.

    Product
    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-3134-2017·2017-09-27

    BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures

    BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.

    Product
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growt
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2254-2016·2016-07-27

    Roche Recalls cobas EGFR Mutation Test V2 Due to False Negatives

    Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.

    Product
    cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons
    Category
    Medical Device
    Distribution
    0 states