Events

Recall of Device Recall PREVI Isola System

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
    63019
  • Event Risk Class
    Class 2
  • Event Number
    Z-0023-2013
  • Event Initiated Date
    2012-08-28
  • Event Date Posted
    2012-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112305
  • 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
    Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Reason
    The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
  • Action
    bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.

Device

Device Recall PREVI Isola System
  • Model / Serial
    Serial numbers AS180-00001 to AS180-00376.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.
  • Product Description
    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. || Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
  • 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