Events

Recall of Device Recall Perkin Elmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkin Elmer Life And Analytical.

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
    31703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0879-05
  • Event Initiated Date
    2005-03-11
  • Event Date Posted
    2005-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38370
  • 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
    System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry - Product Code NQL
  • Reason
    Pump failure may effect data integrity.
  • Action
    Perkin Elmer notified US Customers by letter on 3/11/05. Instructions were provided to service engineers for preventative maintenance. During the week of 5/5/05, the firm is issuing a recall letter recalling the solvents and solutions of these kits. The firm will send a Service Engineer to oversee destruction and maintenance of the pump.

Device

Device Recall Perkin Elmer
  • Model / Serial
    Catalog Number: MS-8970 Lot numbers: 252208, 257031, 258928, 258937, 259588, 263097, 267166 , 267628, 268256, 268258, 268403, 268404, 268675
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR,SC
  • Product Description
    Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
  • Manufacturer
    Perkin Elmer Life And Analytical

Manufacturer

Perkin Elmer Life And Analytical
  • Manufacturer Address
    Perkin Elmer Life And Analytical, 331 Treble Cove Rd, North Billerica MA 01862-2849
  • Source
    USFDA