Events

Recall of Device Recall Vitek 2 ASTYS07 REF 414 967

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
    70868
  • Event Risk Class
    Class 2
  • Event Number
    Z-1602-2015
  • Event Initiated Date
    2015-03-27
  • Event Date Posted
    2015-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135322
  • 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 test kits have out-of-range-low (oorl) flucytosine qc results for candida krusei atcc 6258.
  • Action
    The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.

Device

Device Recall Vitek 2 ASTYS07 REF 414 967
  • Model / Serial
    lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220, 30-OCT-15; lot 287324240, 30-OCT-15; lot 287326220, 19-NOV-15; lot 287327620, 03-DEC-15; lot 287329620, 23-DEC-15; lot 287330520, 01-JAN-16; lot 287331920, 15-JAN-16; lot 287332520, 21-JAN-16; lot 287332522, 21-JAN-16; lot 287334810, 13-FEB-16; lot 287335420, 19-FEB-16; lot 287336220, 27-FEB-16; lot 287337620, 12-MAR-16; lot 287338020, 16-MAR-16; lot 287340140, 06-APR-16; lot 287341820, 23-APR-16; lot 287341822, 23-APR-16; lot 287344620, 21-MAY-16; lot 287344622, 21-MAY-16; lot 287346710, 11-JUN-16; lot 287346720, 11-JUN-16; lot 287350120, 15-JUL-16; and lot 287350122, 15-JUL-16.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
  • Product Description
    Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
  • 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