Events

Recall of Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Focus Diagnostics 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
    47459
  • Event Risk Class
    Class 2
  • Event Number
    Z-1764-2008
  • Event Initiated Date
    2007-07-06
  • Event Date Posted
    2008-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69534
  • 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
    Enzyme Linked Immunoabsorbent Assay - Product Code LGC
  • Reason
    A small percentage of samples tested in specific lots, the hsv common antigen band appears lighter (less reactive) than the reading control band. reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
  • Action
    Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.

Device

Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit
  • Model / Serial
    Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
  • Product Description
    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G || Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Manufacturer Address
    Focus Diagnostics Inc, 10703 Progress Way, Cypress CA 90630-4714
  • Source
    USFDA