Events

Recall of Device Recall Cepheid Xpert MRSA/S Blood Culture

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
    60481
  • Event Risk Class
    Class 3
  • Event Number
    Z-0453-2012
  • Event Initiated Date
    2011-11-17
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105528
  • 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
    in vitro diagnostic MRSA - Product Code NQX
  • Reason
    Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the xpert mrsa/sa bc (blood culture) product.
  • Action
    On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Device

Device Recall Cepheid Xpert MRSA/S Blood Culture
  • Model / Serial
    Lots affected: 2803 and 3001
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution in US.
  • Product Description
    Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
  • Manufacturer
    Cepheid

Manufacturer

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