Events

Recall of Device Recall Premier Platinum HpSA

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
    25295
  • Event Risk Class
    Class 2
  • Event Number
    Z-0465-03
  • Event Initiated Date
    2002-12-26
  • Event Date Posted
    2003-01-23
  • 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=25560
  • 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
    Helicobacter Pylori - Product Code LYR
  • Reason
    Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
  • Action
    The firm mailed notices to their affected customers on 12/26/2002. The consignees were instructed to visually and physically inspect the seals on each microwell pouch for gaps. If properly sealed, the use of the microwells may be continued. Test wells in pouches with defective seals are to be quarantined and destroyed. The customers are asked to report back to the firm. All test microwell plates in defective pouches will be replaced by the firm.

Device

Device Recall Premier Platinum HpSA
  • Model / Serial
    Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03;  Kit Catalog #601348
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • Product Description
    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
    Meridian Bioscience Inc

Manufacturer

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