Events

Recall of Device Recall BEC Growth Chek Microbial Suspension Candida albicans CA1 (100 dose)

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

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
    50821
  • Event Risk Class
    Class 3
  • Event Number
    Z-1043-2009
  • Event Initiated Date
    2009-01-13
  • Event Date Posted
    2009-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77408
  • 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
    Direct Antigen Candida Spp. Id - Product Code LRF
  • Reason
    Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
  • Action
    The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail aschuler@lexamed.net.

Device

Device Recall BEC Growth Chek Microbial Suspension Candida albicans CA1 (100 dose)
  • Model / Serial
    Lot #121208, Expiration Date: 2-12-09.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: Utah
  • Product Description
    BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 || Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.
  • Manufacturer
    Lexamed

Manufacturer

Lexamed
  • Manufacturer Address
    Lexamed, 705 Front St, Toledo OH 43605-2107
  • Manufacturer Parent Company (2017)
    Lexamed
  • Source
    USFDA