The Recall Desk

Hazard

Erroneous Test Results recalls

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

What the numbers show

Total
18
Critical
0
Severe
0
Most recent
2026-08-26

Of the 18 erroneous test 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 0 (0%) 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 erroneous 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.

1–18 of 18

  • HighFDA (Devices)·Z-2974-2026·2026-08-26

    Beckman Coulter DxC 500 AU Analyzer Software Defect Recall

    Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.

    Product
    Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2024·2024-04-03

    Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error

    Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially erroneous patient test results.

    Product
    VITROS Performance Verifier II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2024·2024-03-13

    VITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing

    The VITROS 3600 Immunodiagnostic System is being recalled due to potential aspiration of sample containers during laboratory processing, which may result in erroneous test results.

    Product
    VITROS 3600 Immunodiagnostic System (New and Refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2024·2024-03-13

    VITROS XT7600 System Aspiration Risk During Sample Processing

    Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.

    Product
    VITROS XT7600 Integrated System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2024·2023-11-01

    Smiths Medical Blood Sampling Kits Missing Critical Filter Component

    Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.

    Product
    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2144-2023·2023-07-26

    Beckman Coulter DxA Automation System software defect may produce erroneous patient test results

    A software defect in the Beckman Coulter DxA Automation System may cause tests to be performed on incompatible tube types, potentially producing inaccurate patient results. Affected systems were distributed in the US and internationally.

    Product
    Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0363-2023·2022-12-14

    IgM and IgA Assay Kits Recalled for Test Carryover Risk

    Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.

    Product
    IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2021·2021-05-12

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume

    Greiner Bio-One is recalling VACUETTE blood collection tubes because insufficient draw volume may cause erroneous coagulation test results.

    Product
    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Control Due to Erroneous Results

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.

    Product
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2017·2017-03-08

    Phadia Recalls EliA Sample Diluent Due to Liquid Level Detection Issues

    Phadia US Inc is recalling EliA Sample Diluent because liquid level detection problems in Phadia 250 instruments caused erroneous test results.

    Product
    EliA Sample Diluent, Article number, 83-1023-01
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1035-2013·2013-04-10

    Beckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems

    Beckman Coulter is recalling 956 UniCel DxC 600i Synchron Access Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2013·2013-04-10

    Beckman Coulter Synchron LXi 725 Clinical System Recalled for Defective Pulley

    Beckman Coulter is recalling 83 Synchron LXi 725 Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2013·2013-04-10

    Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking erroneous test results.

    Product
    Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or
    Category
    Medical Device
    Distribution
    Distributed nationwide