Events

Recall of Device Recall Xpert MRSA

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
    74803
  • Event Risk Class
    Class 2
  • Event Number
    Z-2548-2016
  • Event Initiated Date
    2016-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148487
  • 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
    System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
  • Reason
    Internal investigation found the certain lots of mrsa kits have the potential for performance issues at lower positive sample concentrations.
  • Action
    Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.

Device

Device Recall Xpert MRSA
  • Model / Serial
    Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.
  • Product Description
    Xpert MRSA || Catalog GXMRSA-120, Rev. AJ || Microbiology: || The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System || (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
  • Manufacturer
    Cepheid

Manufacturer

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