BEUDAMED
    FDA Enforcement Class II 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 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0780-2017
    Event ID
    75588
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    October 13, 2016
    Classification Date
    December 16, 2016
    Termination Date
    September 13, 2018
    Address
    68 Elm St, N/A, Hopkinton, MA, 01748-1602, United States

    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.

    Code Info

    Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099

    Distribution

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

    Quantity

    33312