The Recall Desk

Hazard

Inaccurate Results recalls

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

What the numbers show

Total
469
Critical
0
Severe
6
Most recent
2026-09-02

Of the 469 inaccurate results recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (1%) 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 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.

326–350 of 469

  • ModerateFDA (Devices)·Z-0488-2016·2015-12-30

    Ameditech 12-Panel Dip Drug Screen Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screen kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0495-2016·2015-12-30

    Ameditech DrugSmart 12 Test Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart 12 Test Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0519-2016·2015-12-30

    Ameditech ProScreen 10 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2016·2015-11-25

    Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    EDI BZO UNCUT SHEET-CARD, Item No. 100170 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 drug strips, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2016·2015-11-25

    Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.

    Product
    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2016·2015-11-25

    Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP 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 dr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2016·2015-11-25

    Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2016·2015-11-04

    Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes

    Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.

    Product
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2016·2015-10-14

    Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors

    Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.

    Product
    Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2015·2015-09-30

    Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error

    Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.

    Product
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2814-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 1,213 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2741-2015·2015-09-16

    Siemens Recalls Dimension CREA Tests for Falsely Depressed Results

    Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.

    Product
    Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2015·2015-09-16

    Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.

    Product
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2015·2015-09-09

    Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs

    Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.

    Product
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2015·2015-09-09

    Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results

    Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.

    Product
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2446-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.

    Product
    Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2015·2015-07-08

    Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results

    Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.

    Product
    ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2015·2015-07-08

    Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

    Product
    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2015·2015-07-08

    Roche Lactate Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.

    Product
    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2015·2015-07-08

    Roche Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.

    Product
    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2015·2015-07-08

    Axis-Shield Homocysteine Reagent Recalled for Performance Deterioration

    Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test results.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide