Events

Recall of Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325

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
    73585
  • Event Risk Class
    Class 2
  • Event Number
    Z-1596-2016
  • Event Initiated Date
    2016-02-24
  • Event Date Posted
    2016-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144536
  • 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
    Product may lead to false susceptible results of staphylococcus spp., enterococcus spp., and s. agalactiae to minocycline.
  • Action
    Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. ¿ For the referenced test kit (VITEK¿ 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory.¿ o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK¿ 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioM¿rieux instrument documentation. ¿ Complete the attached Acknowledgement Form and return it to their local bioM¿rieux representative. For questions regarding this recall call 314-731-8526.

Device

Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325
  • Model / Serial
    Lot/Serial: 485368220 Expiry: 12-JAN-17
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to China  Taiwan region; No US/military/government distribution.
  • Product Description
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is 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 to antimicrobial agents when used as instructed in the Product Information manual.
  • 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