BEUDAMED
    FDA Recall Terminated

    PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS

    Recall: Z-0780-2017 · Initiated October 13, 2016

    Recall

    Recall Number
    Z-0780-2017
    Event Number
    75588
    Firm
    PerkinElmer, Inc
    FEI Number
    3009981484
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 13, 2016
    Terminated
    September 13, 2018
    Address
    68 Elm St, Hopkinton, MA, 01748-1602

    Description

    PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS

    Reason

    Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.

    Action

    PerkinElmer initiated the recall on Sept 1. 2016 by letter dated . Customers were told of the defect, potential for inaccurate measurements, and requested to inspect for the lots stop using and destroy. Replacement product to be provided. Accounts asked to compelte Response form. Questions call your PerkinElmer representative.

    Distribution

    IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore

    Quantity

    33312