Events

Recall of Device Recall Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit GXCT/NGSWAB50

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
    71841
  • Event Risk Class
    Class 3
  • Event Number
    Z-2431-2015
  • Event Initiated Date
    2015-07-27
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139200
  • 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
    Dna-reagents, neisseria - Product Code LSL
  • Reason
    Firm determined that some lots of ct/ng swab 50 and ct/ng urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
  • Action
    Notification letters dated July 28 and 29th to all affected customers via Federal Express..

Device

Device Recall Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit GXCT/NGSWAB50
  • Model / Serial
    Part number: CT/NGSWAB-50: Lot numbers: 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, Flock swab expires end of July 2015. Kit expires October 2015. Lot numbers 26N121H, and 28N134D.- Cleaning swabs expire end of June 2016. Kits expires November 2016.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.
  • Product Description
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: || Part number CT/NGSWAB-50; || Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
  • Manufacturer
    Cepheid

Manufacturer

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