BEUDAMED
    FDA Recall Terminated

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    Recall: Z-2685-2017 · Initiated May 15, 2017

    Recall

    Recall Number
    Z-2685-2017
    Event Number
    77267
    Firm
    Perkinelmer Life Sciences, Inc.
    FEI Number
    1000513616
    Product Code
    JJN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 15, 2017
    Posted
    May 22, 2017
    Terminated
    March 2, 2023
    Address
    549 Albany St, Boston, MA, 02118-2512

    Description

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    Reason

    Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

    Action

    Perkin Elmer issued URGENT: Field Correction letter on 5/15/17 and accompanied with the GE HealthCare Important Product Information letter The notifications will be delivered to the end customer by email facilitated through PerkinElmer Technical Support group located in Akron Ohio. Technical Support will ensure the customers receive the both letters and understand the recommended actions. Accounts requested to complete the enclosed Response Form. Questions regarding the actions to be taken, as outlined in the GE HealthCare letter, should be directed via email to [email protected] or via phone (in the US) 011 44 800 515313, (in the UK) 0800 515 313, and (rest of world) +44-800 515 313.

    Distribution

    US Nationwide Distribution

    Quantity

    241 instruments