Events

Recall of Device Recall Cepheid Xpert Flu A Panel (GXFLUPANELCE10)

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

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
    55079
  • Event Risk Class
    Class 3
  • Event Number
    Z-1652-2010
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2010-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91843
  • 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
    Reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identific - Product Code OPU
  • Reason
    Firm has had an increasing number of customer complaints regarding higher than expected indeterminate test results due to "invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.
  • Action
    Cepheid issued a notification to consignees regarding the affected product. Additional instructions were provided to consignees in order to avoid further "Indeterminate Results". For further information, contact Cepheid at 1-888-336-2743.

Device

Device Recall Cepheid Xpert Flu A Panel (GXFLUPANELCE10)
  • Model / Serial
    Lot Number: 00501 (Expires 2010 08 08)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
  • Product Description
    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
  • Manufacturer
    Cepheid

Manufacturer

Cepheid
  • Manufacturer Address
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA