Events

Recall of Device Recall MAS Omni Immune PRO Controls

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microgenics Corporation.

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
    67011
  • Event Risk Class
    Class 3
  • Event Number
    Z-1930-2014
  • Event Initiated Date
    2013-12-02
  • Event Date Posted
    2014-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124514
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    The constituent, inhibin a, was removed from mas omni immune and mas omni immune pro controls; however the package insert was not updated to reflect the change.
  • Action
    Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.

Device

Device Recall MAS Omni Immune PRO Controls
  • Model / Serial
    Part Number Lot number  OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S   All lots have an expiration date of 10/31/2015.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
  • Product Description
    MAS Omni Immune PRO Controls
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Manufacturer Address
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA