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.

126–147 of 147

  • HighFDA (Devices)·Z-0568-2016·2016-01-06

    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 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg 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 ser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0442-2016·2015-12-30

    Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0440-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests due to the potential for reporting erroneous results, specifically false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2016·2015-12-02

    Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results

    Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.

    Product
    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling two WIZARD2 gamma counters due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1 000 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-2126-2015·2015-07-29

    Perkinelmer Recalls WIZARD2 Gamma Counters Due to Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 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-2124-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce 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-2127-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that may produce 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-2125-2015·2015-07-29

    Perkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    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-2129-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 18 WIZARD2 gamma counters because a barcode label error may produce 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-2130-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce 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
  • HighFDA (Devices)·Z-1521-2015·2015-05-06

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

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems with software version 2.8 or below due to a potential anomaly that may cause the device to process samples with the wrong cartridge, leading to erroneous patient results.

    Product
    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vi
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1060-2015·2015-02-11

    Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces

    Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.

    Product
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2051-2014·2014-07-23

    Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

    Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

    Product
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2014·2014-04-09

    Roche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results

    Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2014·2014-03-26

    Medical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology software releases 5.6 through 6.14 because of a potential for erroneous result reporting.

    Product
    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2014·2014-03-19

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results

    Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.

    Product
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results

    Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2013·2013-04-10

    Beckman Coulter Access Immunoassay System Recalled for Defective Belt Pulley

    Beckman Coulter is recalling Access Immunoassay Systems because a defective belt pulley creates debris that may cause erroneous test results.

    Product
    Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0701-2013·2013-01-30

    BD MAX Clinical Diagnostic Instruments Recalled for Minor Defects

    Becton Dickinson is recalling 86 BD MAX clinical diagnostic instruments because minor defects may cause erroneous test results.

    Product
    Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2258-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2012·2012-08-29

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly

    Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.

    Product
    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualita
    Category
    Medical Device
    Distribution
    Distributed nationwide