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.

51–72 of 72

  • SevereFDA (Devices)·Z-0561-2016·2016-01-06

    Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo panels that may produce falsely negative Voges-Proskauer results for Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2016·2016-01-06

    Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2015·2014-12-03

    Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

    Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predomi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2014·2014-04-30

    BioMerieux Recalls FB Reagent Due to False Negative Test Results

    BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.

    Product
    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2014·2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue caused false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1477-2014·2014-04-30

    BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

    BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue can cause false negative results in Rapid ID 32 strips and API biochemical tests.

    Product
    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2014·2014-03-26

    Alere Triage TOX Drug Screen Recalled for False Negative PCP Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.

    Product
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Tri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2014·2014-03-19

    BioMerieux PREVI Isola System Recalled for Potential False Negative Results

    BioMerieux is recalling 471 PREVI Isola Systems because they may fail to dispense urine samples, potentially leading to false negative growth results.

    Product
    bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0869-2014·2014-02-05

    BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.

    Product
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0841-2014·2014-02-05

    BioMérieux Recalls ZYM B Reagent Due to Visual Defect and False Negatives

    BioMérieux is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in API biochemical tests.

    Product
    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2014·2014-02-05

    BioMérieux Recalls API NH Kits Due to ZYM B Reagent Defect

    BioMérieux is recalling API NH kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

    Product
    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2014·2014-01-29

    BD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing

    Becton Dickinson is recalling 33 kits of the BD GeneOhm Cdiff Assay because an incorrect reagent was packed, which may cause false negative results for C. difficile.

    Product
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0572-2014·2014-01-01

    Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives

    Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.

    Product
    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2014·2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2014·2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2014·2013-10-23

    OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk

    Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.

    Product
    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2013·2013-04-10

    Polymedco OC-Light iFOBT Test Strips Recalled for Potential False Negatives

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2013·2013-04-10

    Polymedco Recalls OC-Light iFOBT Test Strips Due to Stability Issues

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2013·2013-02-13

    OPTIGEN Food 30 Allergen Testing Kits Recalled for Potential False Negatives

    Hitachi Chemical Diagnostics is recalling 20 kits of OPTIGEN Food 30 allergen testing products due to a potential low fill volume that could cause false negative results.

    Product
    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0762-2013·2013-02-06

    Roche COBAS TaqMan MTB Test Definition Files Recalled for False Negative Risk

    Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.

    Product
    COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0023-2013·2012-10-17

    BioMérieux PREVI Isola System Recall for False Negative Results

    BioMérieux is recalling PREVI Isola Systems because they may fail to dispense specimens, leading to false negative microbiological test results.

    Product
    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide