Events

Recall of Device Recall VITEK 2 ASTST01 Streptococcus Susceptibility Card

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

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
    64327
  • Event Risk Class
    Class 2
  • Event Number
    Z-1013-2013
  • Event Initiated Date
    2013-02-06
  • Event Date Posted
    2013-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115837
  • 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
    Susceptibility test cards, antimicrobial - Product Code LTW
  • Reason
    The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
  • Action
    bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.

Device

Device Recall VITEK 2 ASTST01 Streptococcus Susceptibility Card
  • Model / Serial
    lot number: 540274420
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in HI.
  • Product Description
    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. || For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA