Events

Recall of PerkinElmer 20ul Clear RoboRack Tip, Pipette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75588
  • Event Risk Class
    Class 2
  • Event Number
    Z-0780-2017
  • Event Initiated Date
    2016-10-13
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150859
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • 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.

Device

PerkinElmer 20ul Clear RoboRack Tip, Pipette
  • Model / Serial
    Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore
  • Product 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
  • Manufacturer
    PerkinElmer, Inc

Manufacturer

PerkinElmer, Inc
  • Manufacturer Address
    PerkinElmer, Inc, 68 Elm St, Hopkinton MA 01748-1602
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA