The Recall Desk

Hazard

Delayed Results recalls

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

What the numbers show

Total
54
Critical
0
Severe
0
Most recent
2026-08-12

Of the 54 delayed 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 delayed 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.

26–50 of 54

  • HighFDA (Devices)·Z-1222-2022·2022-06-08

    Medical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect

    Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.

    Product
    DYNEX Agility, Agility Analyzer, Model No. 67000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2022·2022-04-20

    Hydroxybutyrate Test Kits Recalled Due to Improper Storage

    Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.

    Product
    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0525-2022·2022-02-02

    API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect

    Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.

    Product
    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either autom
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1489-2021·2021-05-05

    Ortho-Clinical VITROS Black Reference Slides Recalled for Mislabeling

    Ortho-Clinical Diagnostics is recalling VITROS Black Reference Slides incorrectly labeled as White Reference Slides, which may cause analyzer delays.

    Product
    VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Pos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1673-2020·2020-04-15

    Beckman Coulter LabPro Data Management System Software Update Recall

    Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.

    Product
    LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2019·2019-07-24

    Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues

    Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.

    Product
    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educati
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0600-2019·2018-12-19

    Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk

    Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.

    Product
    AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0485-2019·2018-11-28

    Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing

    Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.

    Product
    Tosoh AIA-900 immunoassay Analyzer
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1220-2018·2018-09-12

    AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information

    PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.

    Product
    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2591-2018·2018-08-08

    ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures

    ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.

    Product
    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2575-2018·2018-08-08

    Randox Liquid Cardiac Control Level 3 Recalled for Precision Issues

    Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.

    Product
    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2059-2018·2018-06-13

    Randox RX Imola Analyzers Recalled for Software Termination Issue

    Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.

    Product
    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1530-2018·2018-05-02

    Menarini Silicon Biosystems Recalls CellSearch Circulating Tumor Cell Kits

    Menarini Silicon Biosystems is recalling CellSearch Circulating Tumor Cell Kits because unusually high image counts may delay result reporting.

    Product
    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1077-2018·2018-03-28

    Epigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs

    Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit because the diagnostic test may produce invalid runs, potentially delaying results.

    Product
    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0254-2018·2017-12-20

    Ortho-Clinical enGen Track System Software Recall for Result Delays

    Ortho-Clinical Diagnostics is recalling 16 enGen Track Systems with TCAutomation Software Version 4.2 due to a software anomaly that may delay result reporting.

    Product
    enGen Track System with TCAutomation Software Version 4.2
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0648-2017·2016-11-30

    Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags

    Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying test results.

    Product
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2580-2016·2016-08-24

    Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1956-2016·2016-06-22

    Beckman Coulter Access 2 Immunoassay System Recall for Thermal Component Defects

    Beckman Coulter is recalling four Access 2 Immunoassay Systems because missing thermal components may cause internal temperature excursions, delaying patient result reporting.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1399-2015·2015-04-15

    Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error

    Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.

    Product
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2687-2014·2014-10-01

    Beckman Coulter Recalls Sample Probe Cables for Immunoassay Systems

    Beckman Coulter is recalling sample probe cables for UniCel immunoassay systems because nonconforming units may cause delays in reporting test results.

    Product
    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect

    Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.

    Product
    Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1738-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.

    Product
    enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modifica
    Category
    Medical Device
    Distribution
    Distributed nationwide