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.

101–125 of 147

  • HighFDA (Devices)·Z-1341-2018·2018-04-18

    Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

    Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous results.

    Product
    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.

    Product
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2018·2018-04-11

    Life Technologies Recalls Oncomine Dx Target Test User Guides

    Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.

    Product
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detec
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0605-2018·2018-02-21

    Beckman Coulter Recalls Unpaired Lyophilized Chemistry Calibrator Lots

    Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.

    Product
    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based p
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2017·2016-11-16

    Roche COBAS INTEGRA c111 Analyzer Recall for Software Error

    Roche is recalling 139 COBAS INTEGRA c111 analyzers due to a software error that may cause erroneous test results.

    Product
    Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2016·2016-06-15

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2016·2016-06-15

    Ortho VITROS 5600 System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2016·2016-06-15

    Beckman Coulter Lactate Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false low results.

    Product
    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0641-2016·2016-01-20

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2016·2016-01-20

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

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    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, Software Version 2.8 and below, IVD. Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2016·2016-01-20

    Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2016·2016-01-20

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 188 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 22 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label

    Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0632-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2016·2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 60 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, leading to erroneous results.

    Product
    Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2016·2016-01-20

    Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0569-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2016·2016-01-06

    BD Vacutainer K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA blood collection tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which prov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2016·2016-01-06

    BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

    Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

    Product
    BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing seru
    Category
    Medical Device
    Distribution
    Distributed nationwide