Events

Recall of Device Recall HSV2 Primers

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

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
    65770
  • Event Risk Class
    Class 2
  • Event Number
    Z-2085-2013
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120130
  • 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
    Bacteriophage and controls, b. Anthracis lysis - Product Code NYQ
  • Reason
    Firm received complaints that hsv-2 primers failed to amplify hsv-2 dna.
  • Action
    Life Technologices sent an Urgent Product Recall letter dated May 13, 2013 by certified mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use and dispose all affected units. Customers were advised to complete the Customer Response Sheet included for product/quantities consumed, and send e-mail to techsupport@lifetech.com. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.

Device

Device Recall HSV2 Primers
  • Model / Serial
    Catalog #18081020, Lot #1368760 & Lot #1312093
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of DE, IA, MN, and NC.
  • Product Description
    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Manufacturer Address
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA