Events

Recall of Device Recall Oxoid Infectious Mononucleosis Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel, 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
    34612
  • Event Risk Class
    Class 3
  • Event Number
    Z-0786-06
  • Event Initiated Date
    2006-02-14
  • Event Date Posted
    2006-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44188
  • 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
    System, Test, Infectious Mononucleosis - Product Code KTN
  • Reason
    Some units exhibit weak false-positive reactions with some negative patient serum.
  • Action
    The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed. The distributor was audited by FDA to assure subrecall

Device

Device Recall Oxoid Infectious Mononucleosis Test
  • Model / Serial
    Lot 382735, Exp. 2006/06/30
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide-Distribution was made to a New Jersey distributor.
  • Product Description
    Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
  • Manufacturer
    Remel, Inc.

Manufacturer

Remel, Inc.
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, (PO Box 14478, zip 66285-4478), Lenexa KS 66215-3519
  • Source
    USFDA