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.

51–75 of 88

  • HighFDA (Devices)·Z-0378-2018·2018-01-24

    Roche Recalls Automated Analyzers Due to Possible Sample Mismatch

    Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.

    Product
    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2018·2017-12-20

    Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results

    Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.

    Product
    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provid
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0027-2018·2017-10-25

    Hologic Panther System Recalled for Incorrect Incubator Installation

    Hologic is recalling one Panther System unit in Indiana because an incorrect incubator was installed, which may have led to incorrect Aptima Combo 2 assay results.

    Product
    Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2017·2017-04-26

    BD MAX System Software Version 4.44A Recalled for Potential Incorrect Results

    BD Life Sciences is recalling BD MAX System software version 4.44A due to a defect that may cause incorrect result reporting for specific user-defined protocol assays.

    Product
    Software version 4.44A utilized on the BD MAX System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1384-2017·2017-03-08

    Beckman Coulter iChemVELOCITY Urine Chemistry System Recalled for Probe Misalignment

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because probe misalignment or bending can lead to delayed or incorrect patient results.

    Product
    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: keto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2017·2017-02-01

    Softbank II Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.

    Product
    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2017·2017-02-01

    Softbank Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.

    Product
    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system 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 hemoglobin (tHb), hemoglobin derivatives (O2Hb, HH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2526-2016·2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compoun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2016·2016-08-24

    Ab Sciex Mass Spectrometer Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2527-2016·2016-08-24

    Ab Sciex 3200MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling MultiQuant MD software for 3200MD mass spectrometers because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2256-2016·2016-07-27

    Siemens ADVIA Centaur XPT Software Recalled for Potential Result Errors

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XPT system software versions V1.0.1 through V1.1 due to eight identified issues that may affect test results.

    Product
    ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2016·2016-05-25

    AB Sciex Mass Spectrometers Recalled for Incorrect Quantitative Results

    AB Sciex is recalling two models of mass spectrometers used for in vitro diagnostics because they may report incorrect quantitative results under certain conditions.

    Product
    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1665-2016·2016-05-18

    Siemens Dimension Vista Triglyceride Assay Recalled for Interference

    Siemens is recalling Dimension Vista Triglyceride assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Triglycerides (TRIG)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2016·2016-03-16

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry Sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2054-2015·2015-07-15

    Siemens Dimension Vista Systems Recalled for Software Processing Errors

    Siemens is recalling Dimension Vista Systems due to software issues that may cause samples to stop processing or deliver incorrect reagents, leading to unexpected test results.

    Product
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2015·2015-01-14

    Horiba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues

    Horiba Medical is recalling ABX PENTRA Reagent Containers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2014·2014-08-13

    PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

    PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

    Product
    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1991-2014·2014-07-09

    Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.

    Product
    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2014·2014-04-09

    Siemens Medical Solutions Recalls IMMULITE 2000 and VersaCell Diagnostic Instruments

    Siemens Medical Solutions Diagnostics is recalling 1,006 IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems due to a potential for incorrect test results.

    Product
    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2014·2014-02-26

    Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings

    Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.

    Product
    Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state