The Recall Desk

Hazard

Incorrect Results recalls

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

What the numbers show

Total
88
Critical
4
Severe
2
Most recent
2026-01-21

Of the 88 incorrect results recalls we have scored against our rubric, 4 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (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 incorrect 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.

1–25 of 88

  • CriticalFDA (Devices)·Z-1021-2026·2026-01-21

    Libre 3 Plus sensors recalled in a second lot over carbon build up

    Abbott Diabetes Care is recalling 1,663,241 FreeStyle Libre 3 Plus sensors, REF 78768-01, because carbon build up in the sensor may result in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1023-2026·2026-01-21

    Libre 3 Plus sensors recalled over carbon build up causing low readings

    Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1020-2026·2026-01-21

    Glucose monitoring sensors recalled over carbon build up causing low readings

    Abbott Diabetes Care is recalling 1,060,723 FreeStyle Libre 3 sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1022-2026·2026-01-21

    Libre 3 Plus sensors, REF 78769-01, recalled over carbon build up

    Abbott Diabetes Care is recalling 258,913 FreeStyle Libre 3 Plus sensors, REF 78769-01, because carbon build up in the sensor may result in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0583-2026·2025-12-03

    Skin cancer aid recalled because it may not meet specifications

    DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.

    Product
    DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2681-2024·2024-08-28

    Alinity hq Analyzer May Generate Incorrect Blood Test Results

    Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.

    Product
    Alinity hq Analyzer, REF: 09P68-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2624-2023·2023-09-27

    FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.

    Product
    VITROS XT Chemistry Products ALKP Slides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2023·2023-06-28

    Serrated Blade Applicator Kit packaging may contain wrong applicator size

    Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.

    Product
    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1349-2023·2023-04-12

    Abbott Alinity m System Recall: Missing Components and Improper Calibration

    Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.

    Product
    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0175-2022·2021-11-03

    Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results

    AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.

    Product
    Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2021·2021-07-28

    Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results

    SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.

    Product
    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and tra
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 195 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 132 ADVIA 2120 hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2021·2021-01-27

    Roche Cobas Infinity Software Error May Allow Unreliable Lab Results

    Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.

    Product
    A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2021·2021-01-13

    Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.

    Product
    CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2021·2021-01-06

    Roche cobas pro integrated solutions recalled for potential incorrect results

    Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.

    Product
    Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2021·2021-01-06

    Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors

    Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.

    Product
    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems 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 Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    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
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system 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 Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2020·2020-06-24

    Abbott Alinity C Processing Module Recalled for Incorrect Patient Results

    Abbott is recalling 421 Alinity C Processing Modules because they may generate incorrect results for specific chemistry assays.

    Product
    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2251-2020·2020-06-10

    Abbott Accelerator APS Aliquoter Module Recalled for Sample Dilution Risk

    Abbott is recalling 11 Accelerator APS Aliquoter Modules because a clot detection error may cause distilled water to dilute samples, leading to incorrect clinical results.

    Product
    Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay a
    Category
    Medical Device
    Distribution
    Distributed nationwide