The Recall Desk

Hazard

Inaccurate Test Results recalls

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

What the numbers show

Total
63
Critical
1
Severe
1
Most recent
2026-04-29

Of the 63 inaccurate test results recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) 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 inaccurate test results 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.

51–63 of 63

  • ModerateFDA (Devices)·Z-1069-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect

    Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1068-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Reagent Due to Homogeneity Defect

    Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0914-2018·2018-03-14

    Ortho-Clinical VITROS Performance Verifier IV Recall for Storage Labeling

    Ortho-Clinical Diagnostics is recalling 196 units of VITROS Chemistry Products DAT Performance Verifier IV because storage labeling errors may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3118-2017·2017-09-20

    Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover

    Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.

    Product
    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2017·2017-03-15

    Remel Haemophilus Test Medium Recalled for Poor Organism Growth

    Remel Inc is recalling Haemophilus Test Medium agar plates because poor organism growth may result in incorrect susceptibility test results.

    Product
    Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instruc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1252-2015·2015-03-18

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 3,420 RAPIDPoint 405 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1960-2014·2014-07-09

    Siemens ADVIA Centaur HCY Diluent Recalled for Inaccurate Dilution Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HCY Diluent because dilution recovery was lower than reported in the instructions for use.

    Product
    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0794-2014·2014-01-29

    Remel Recalls Oxoid Ampicillin Test Discs Due to Missing Antibiotic

    Remel Inc is recalling 80 packs of Oxoid Ampicillin 10 mcg test discs because some cartridges may contain discs not impregnated with antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2014·2014-01-29

    Remel Recalls Oxoid Norfloxacin Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Norfloxacin 10 mcg antimicrobial susceptibility test discs because some cartridges may contain discs not impregnated with the antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2013·2013-07-31

    Becton Dickinson Recalls Vancomycin Screen Agar Due to Reduced Antimicrobial Levels

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the media may contain reduced levels of vancomycin, potentially affecting test accuracy.

    Product
    BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to pred
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0635-2013·2013-01-16

    Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity

    Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2013·2012-12-26

    BD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results

    Becton Dickinson is recalling 12,250 BD Phoenix PMIC-108 panels because they may produce false intermediate or resistant antibiotic susceptibility results.

    Product
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clini
    Category
    Medical Device
    Distribution
    Distributed nationwide