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.

251–275 of 469

  • ModerateFDA (Devices)·Z-0045-2018·2017-11-01

    Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results

    Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.

    Product
    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2018·2017-10-11

    Binding Site Alpha-1-Antitrypsin Kit Recalled for Low Control Recovery

    The Binding Site Group is recalling 361 Human Alpha-1-Antitrypsin Kits because the high control may recover low and fall out of range.

    Product
    Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3237-2017·2017-10-11

    Radiometer AutoCheck5+ Level 2 Quality Control Ampoules Recalled for Inaccurate Results

    Radiometer America is recalling AutoCheck5+ Level 2 quality control ampoules because they may provide incorrect pCO2 and pO2 results.

    Product
    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3112-2017·2017-09-13

    Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results

    Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.

    Product
    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2613-2017·2017-06-28

    Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference

    Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.

    Product
    ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2017·2017-06-14

    Magellan LeadCare Blood Test Kits Underestimate Lead Concentrations

    Magellan Diagnostics is recalling LeadCare Ultra and Plus test kits because they may underestimate lead levels in venous blood samples.

    Product
    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2017·2017-05-31

    Beckman Coulter Recalls Microalbumin Reagent Due to Potential Out-of-Range Recovery

    Beckman Coulter is recalling Microalbumin Reagent Lot M609458 because it may recover outside the lower limit of the published insert range for Urine Protein Control Level 1.

    Product
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2017·2017-05-24

    Siemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.

    Product
    ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1866-2017·2017-04-26

    BD Viper LT Software Recall Due to Inaccurate Test Results

    BD Diagnostic is recalling BD Viper LT software version 3.00H because it generates lower-than-expected RFU values, which may impact test results.

    Product
    BD Viper LT software, version 3.00H
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1712-2017·2017-04-12

    Siemens ADVIA Chemistry Enzyme 2 Calibrator Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Enzyme 2 Calibrators due to a positive bias of up to 41% in AST and AST_c assay results.

    Product
    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A Kits due to a negative bias in FT4 assays and potential calibration failures on certain systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens recalls ADVIA Centaur Calibrator A kits due to negative bias in FT4 assays and potential calibration failures on specific systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2017·2017-03-01

    Siemens N Latex HCY Reagent Recalled for Stability Issues

    Siemens Healthcare Diagnostics is recalling N Latex HCY Reagent kits due to reduced stability that may cause inaccurate homocysteine test results.

    Product
    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1217-2017·2017-02-22

    Siemens Enzyme II Calibrator Recalled for ALTI Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme II Calibrators because they may cause patient and QC results to shift by up to 10% on the Dimension clinical chemistry system.

    Product
    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1179-2017·2017-02-15

    Ortho-Clinical VITROS UPRO Slides Recalled for Variable Urine Protein Results

    Ortho-Clinical Diagnostics is recalling VITROS UPRO Slides because they may produce variable urine protein results.

    Product
    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2017·2017-02-08

    Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.

    Product
    VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2017·2017-02-01

    Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.

    Product
    Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabol
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1093-2017·2017-02-01

    Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation

    Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.

    Product
    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1072-2017·2017-02-01

    Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.

    Product
    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobuli
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1070-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1067-2017·2017-02-01

    Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.

    Product
    Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis
    Category
    Medical Device
    Distribution
    6 states