Events

Recall of Device Recall VITEK GPS106 Gram Positive 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
    28429
  • Event Risk Class
    Class 2
  • Event Number
    Z-0725-04
  • Event Initiated Date
    2004-01-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31833
  • 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, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
  • Reason
    The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
  • Action
    The firm issued recall letters dated 1/15/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. The firm also issued a 'Second Notification' recall letter dated 3/9/04.

Device

Device Recall VITEK GPS106 Gram Positive Susceptibility Card
  • Model / Serial
    Lot P61X, Exp. 5/12/05
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
  • Product Description
    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.
  • Manufacturer
    bioMerieux Inc

Manufacturer

bioMerieux Inc
  • Manufacturer Address
    bioMerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Source
    USFDA