BEUDAMED
    FDA Recall Terminated

    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows

    Recall: Z-0747-2017 · Initiated June 24, 2016

    Recall

    Recall Number
    Z-0747-2017
    Event Number
    75508
    Firm
    PerkinElmer, Inc
    FEI Number
    3009981484
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2016
    Terminated
    July 31, 2018
    Address
    68 Elm St, Hopkinton, MA, 01748-1602

    Description

    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows

    Reason

    Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing

    Action

    PerkinElmer initiated recall on June 24, 2016 to the Product Manager and was delivered to the customer by email facilitated through PerkinElmer Sales Team.Customers were requested to take the following actions until PerkinElmer's corrective measures are completed: Inspect customer inventory of the 6000689 25 Clear Filter Pipette Tip and identify if the affected lots are present. Complete and return the attached Response Form with the required information. Destroy all quantities of tips from the affected lots. Upon receipt of the return Response Form, a shipment of replacement tips will be shipped.

    Distribution

    Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK

    Quantity

    595 trays (571,200 tips)