BEUDAMED
    43 results · 31ms · Sources: EU EUDAMED, US FDA

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    PRECISION TOOTHBRUSH

    FDA Adverse Event
    Malfunction ·COLGATE-HOYT LABORATORIES·Product code EFW·July 14, 1994

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code DHA·July 30, 2009

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 30, 2025

    ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CFN·September 1, 2017

    THERMACARE LOWER BACK & HIP

    FDA Adverse Event
    Injury ·PFIZER CONSUMER HEALTH CARE·Product code IMD·October 30, 2019

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·September 12, 2023

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·October 18, 2023

    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    cobas infinity central lab, Material Number 07154003001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 18, 2023

    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 8, 2009

    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·November 21, 2023

    epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025

    epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025