The Recall Desk

Hazard

Erroneous Results recalls

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

What the numbers show

Total
147
Critical
1
Severe
5
Most recent
2026-08-26

Of the 147 erroneous results recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (3%) 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 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.

76–100 of 147

  • ModerateFDA (Devices)·Z-2962-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps

    Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.

    Product
    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2020·2020-09-02

    Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides

    Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT7600 Integrated System, Product code 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2020·2020-09-02

    Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results

    Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT3400 Chemistry System, Product code 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2743-2020·2020-08-12

    Normand-Info Remisol Advance Software Recall for Erroneous Lab Results

    Normand-Info is recalling Remisol Advance software version 1.12 because it deletes specific white blood cell and platelet results, potentially leading to erroneous data.

    Product
    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2020·2020-07-22

    Roche MagNA Pure 96 Instrument Recalled for Cross-Contamination Risk

    Roche is recalling 917 MagNA Pure 96 instruments because a specific protocol version fails to activate the drop catcher, posing a risk of cross-contamination and erroneous results.

    Product
    MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2020·2020-07-08

    Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.

    Product
    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2020·2020-01-29

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Analyzers

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test results.

    Product
    iChem VELOCITY Urine Chemistry Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2020·2019-11-20

    PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

    PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

    Product
    Universal Sexual Health Testing Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2020·2019-10-16

    Becton Dickinson Recalls BD Microtainer Z Tubes Due to Damaged Reservoirs

    Becton Dickinson & Company is recalling BD Microtainer Z No Additive Tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2020·2019-10-16

    BD Microtainer Tubes Recalled for Damaged Reservoirs and Erroneous Test Results

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2020·2019-10-16

    BD Microtainer PSTTubes with Lithium Heparin Recalled for Damaged Reservoirs

    Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2020·2019-10-16

    BD Microtainer Tubes Recalled for Damaged Reservoirs Causing Test Errors

    Becton Dickinson is recalling BD Microtainer Tubes with K2E because damaged reservoirs may cause insufficient sample volume and erroneous test results.

    Product
    BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2020·2019-10-16

    BD Microtainer SST- Amber Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer SST- Amber Part/Catalog Number: 365978
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0060-2020·2019-10-16

    BD Microtainer PST Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling BD Microtainer PST Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volume and erroneous test results.

    Product
    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2020·2019-10-16

    BD Microtainer Tubes Recalled Due to Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1364-2019·2019-05-29

    Ortho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems because sample fluid may be dispensed to incorrect positions, potentially causing erroneous assay results.

    Product
    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2019·2019-02-06

    Roche Anti-HAV IgM Test System Recalled for Erroneous Results

    Roche Diagnostics is recalling Anti-HAV IgM test systems due to potential erroneous result messages on the cobas e 602 module.

    Product
    Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium hepar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug

    Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.

    Product
    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2018·2018-07-25

    Siemens Dimension Vista MULTI 2 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 1,195 units of Dimension Vista MULTI 2 SDIL diluent because a defective septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2436-2018·2018-07-25

    Siemens Dimension Vista CTNI Sample Diluent Recalled for Defective Cap Septum

    Siemens Healthcare Diagnostics is recalling 1,446 units of Dimension Vista CTNI Sample Diluent because a defective cap septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2429-2018·2018-07-18

    bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues

    bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.

    Product
    BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2018·2018-07-18

    bioMerieux Recalls mini VIDAS Systems Due to Performance Issues

    bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous test results.

    Product
    BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical s
    Category
    Medical Device
    Distribution
    Distributed nationwide