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    PERKINELMER 226 SAMPLE COLLECTION DEVICE

    FDA Adverse Event
    Death ·PERKINELMER HEALTH SCIENCES, INC.·Product code JKA·December 11, 2013

    QSight(tm) 210 Screening System

    FDA UDI
    Perkinelmer Health Sciences Canada, Inc·00812589020320·The QSight™ 210 MD Screening System includes a ...

    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-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code N/A·July 1, 2014

    PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code PJC·May 31, 2017

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code JQP·June 27, 2014

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code JQP·December 1, 2016

    PerkinElmer 226 Sample Collection Device

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code PJC·December 19, 2017

    EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code PJI·December 5, 2016

    Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code KHO·December 21, 2016

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code CGJ·November 16, 2016

    DELFIA PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code KHO·December 21, 2016

    AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code KHO·December 21, 2016

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Health Sciences, Inc.·August 13, 2014

    DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017

    EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016

    Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Health Sciences, Inc.·December 28, 2016

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Health Sciences, Inc.·January 4, 2017

    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-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Health Sciences, Inc.·August 13, 2014

    AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Health Sciences, Inc.·February 1, 2017