Events

Recall of Device Recall Premier CMV IgG Elisa Kits

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
    26505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1127-03
  • Event Initiated Date
    2003-06-18
  • Event Date Posted
    2003-08-12
  • 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=27792
  • 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
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
  • Reason
    The low positive standard kit component is losing potency that may result in false positive test results.
  • Action
    The firm notified their customers by telephone and fax on 6/18/2003.

Device

Device Recall Premier CMV IgG Elisa Kits
  • Model / Serial
    Lot Numbers: #03022371 and #03022472. All lots Exp Date: 2004-07.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
  • Product Description
    Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
  • Manufacturer
    Meridian Bioscience Inc

Manufacturer

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