The Recall Desk

Hazard

False Negative recalls

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

What the numbers show

Total
171
Critical
2
Severe
4
Most recent
2026-09-02

Of the 171 false negative recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) are Severe.

Which agencies issued them

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 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 171

  • LowFDA (Devices)·Z-0505-2016·2015-12-30

    Ameditech iCup DX 6 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 6 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0527-2016·2015-12-30

    Ameditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0503-2016·2015-12-30

    Ameditech iCup DX 11 Panel Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling iCup DX 11 Panel tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2016·2015-11-25

    Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of
    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-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagent because it may produce falsely decreased results when used with certain drugs.

    Product
    Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2015·2015-06-03

    Alere i Influenza A & B kits recalled for false negative risk

    Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.

    Product
    Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2015·2015-03-11

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.

    Product
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1024-2015·2015-02-04

    Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.

    Product
    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2015·2015-02-04

    Beckman Coulter Lactate Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.

    Product
    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2015·2014-12-17

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement because it may cause false negative Legionella test results.

    Product
    Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2015·2014-12-03

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results

    Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.

    Product
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2015·2014-11-19

    Remel Legionella Growth Supplement Recalled for Potential False Negative Results

    Remel Inc is recalling Legionella BCYE Growth Supplement because it may fail to recover Legionella pneumophila, leading to false negative identification.

    Product
    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2671-2014·2014-10-01

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HCV Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HCV Reagent Packs due to signal loss that may cause false negative test results for hepatitis C.

    Product
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagen
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2232-2014·2014-08-20

    BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits

    BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.

    Product
    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction w
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-2170-2014·2014-08-20

    Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges

    Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.

    Product
    Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2168-2014·2014-08-20

    Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates

    Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.

    Product
    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of tox
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1474-2014·2014-04-30

    Remel Recalls Oxoid Legionella Pneumo Groups 2-14 Test Kits

    Remel Inc is recalling two boxes of Oxoid Legionella Pneumo Groups 2-14 test kits because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14, 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, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1473-2014·2014-04-30

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Risk

    Remel Inc is recalling specific lots of Oxoid Legionella Latex Test kits because a reagent may produce false negative results.

    Product
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    11 states