Events

Recall of Device Recall IMO402 Mononucleosis Rapid Test Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego, 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
    64790
  • Event Risk Class
    Class 3
  • Event Number
    Z-1148-2013
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117087
  • 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
    Alere san diego is recalling the clearview mononucleosis cassette because the positive control included in the rapid test may produce false negative results.
  • Action
    Alere sent an Urgent Medical Device Recall letter dated February 26, 2013, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers with unused product remaining are instructed to immediately discard it. Investigations of customer complaints indicate that the positive control included with this lot may produce false negative results. Customers are instructed to return the attached Verification form. Customers that have consumed all product are instructed to indicate zero under "Quantity Discarded" and complete and fax back the form. Replacement product will be provided for any unused portion of the affected lot based on completion and return of the attached Verification Form. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at later.flow.support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.

Device

Device Recall IMO402 Mononucleosis Rapid Test Device
  • Model / Serial
    The affected control lot number is 11030386.  Lot/Unit Codes: MON1040008 & MON1040016.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
  • Product Description
    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 || The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA