Events

Recall of Device Recall Vitek 2 ASTP640 REF 418 579

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
    70645
  • Event Risk Class
    Class 3
  • Event Number
    Z-1402-2015
  • Event Initiated Date
    2015-02-25
  • Event Date Posted
    2015-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134237
  • 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 outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
  • Action
    Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioM¿rieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.

Device

Device Recall Vitek 2 ASTP640 REF 418 579
  • Model / Serial
    lot 740340920, expiration 14APR16; lot 740350820, expiration 22JUL16;
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Product Description
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
  • 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