Events

Recall of Premier Toxins A and B

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Meridian Bioscience 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
    27346
  • Event Risk Class
    Class 3
  • Event Number
    Z-0062-04
  • Event Initiated Date
    2003-09-23
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29720
  • 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
    Reagents, Clostridium Difficile Toxin - Product Code LLH
  • Reason
    The kits were packaged with incorrect dispensing pipettes.
  • Action
    The firm notified their affected consignees by letter on 9/23/2003.

Device

Premier Toxins A and B
  • Model / Serial
    Lots 616096.095, -096, and -097. Expiration Date: 23 Jul 03.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were shipped to consignees located nationwide, and into New Zealand, Haiti, Belgium, Italy, Brazil, Australia, Canada, and Chile.
  • Product Description
    Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
  • Manufacturer
    Meridian Bioscience Inc

Manufacturer

Meridian Bioscience Inc
  • Manufacturer Address
    Meridian Bioscience Inc, 3471 River Hills Dr, Cincinnati OH 45244
  • Source
    USFDA