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.

151–171 of 171

  • ModerateFDA (Devices)·Z-1475-2014·2014-04-30

    BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue

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

    Product
    ZYM B Reagent (REF 70493). The 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 ide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2014·2014-02-05

    Biomerieux Recalls API Listeria Kits Due to ZYM B Reagent Defect

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

    Product
    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM mi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2014·2013-11-06

    bioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues

    bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.

    Product
    chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2014·2013-10-30

    Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error

    Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.

    Product
    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2124-2013·2013-09-18

    Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2013·2013-08-28

    Getinge AccuFast Biological Indicators Recalled for Potential False Negative Results

    Getinge USA is recalling AccuFast Biological Indicators, Lot SR-430, because exposure to certain conditions may cause false negative results during steam sterilization testing.

    Product
    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biol
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1886-2013·2013-08-14

    Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.

    Product
    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2013·2013-08-14

    Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2013·2013-06-19

    Siemens MicroScan Dried Negative Breakpoint Combo 47 Panels Recalled

    Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.

    Product
    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2013·2013-05-15

    Siemens MicroScan MICroSTREP panels recalled for false susceptibility results

    Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.

    Product
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1148-2013·2013-04-24

    Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk

    Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.

    Product
    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2013·2012-12-19

    Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects

    Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.

    Product
    BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2012·2012-09-26

    Steris Recalls Verify Bowie-Dick Test Cards Due to Performance Issues

    Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.

    Product
    Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2012·2012-07-25

    Alere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy

    Alere San Diego is recalling 9,997 Triage Tox+MTD Drug Screen kits because they may produce false positive or negative results due to decreased precision and accuracy.

    Product
    Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2012·2012-07-18

    Alere Triage D-dimer Kits Recalled for Decreased Precision

    Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.

    Product
    Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2012·2012-07-18

    Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results

    Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.

    Product
    Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2012·2012-07-18

    Alere Triage Profiler SOB Panel Recalled for Decreased Precision

    Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.

    Product
    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2012·2012-07-18

    Alere Triage CardioProfiler Panel Recalled for Decreased Precision

    Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause false positive or negative results.

    Product
    Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide