Events

Recall of Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960

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
    75508
  • Event Risk Class
    Class 2
  • Event Number
    Z-0747-2017
  • Event Initiated Date
    2016-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150563
  • 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
    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.

Device

Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960
  • Model / Serial
    Lot Numbers:15470394, 15471775, 1601067, 16071147
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product 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
  • 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