Events

Recall of Xpert GBS

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
    45494
  • Event Risk Class
    Class 3
  • Event Number
    Z-0376-2008
  • Event Initiated Date
    2007-09-05
  • Event Date Posted
    2008-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65632
  • 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
    Nucleic Acid Amplification Assay System, (Group b streptococcus, direct specimen test) - Product Code NJR
  • Reason
    Labeling error: some cartridges may be mislabeled as "xpert ev" instead of "xpert gbs". (the information embedded in the barcode label on the cartridge is correct for xpert gbs and brings up the gbs assay definition file).
  • Action
    Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.

Device

Xpert GBS
  • Model / Serial
    Lot Number : 1402
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
  • Manufacturer
    Cepheid

Manufacturer

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