Events

Recall of CEDIA Tobramycin II Assay

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

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
    66626
  • Event Risk Class
    Class 2
  • Event Number
    Z-0513-2014
  • Event Initiated Date
    2013-10-16
  • Event Date Posted
    2013-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122795
  • 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
    Fluorescence polarization immunoassay, tobramycin - Product Code LFW
  • Reason
    Microgenics corp., part of thermo fisher scientific, is recalling cedia tobramycin ii assay (lot number: 60169764) due to calibration stability problem relating to two complaints received.
  • Action
    Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact mgc@thermofisher.com. For question regarding this recall call 1-800-232-3342.

Device

CEDIA Tobramycin II Assay
  • Model / Serial
    Lot Number: 60169764
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
  • Product Description
    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by || Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific || The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.
  • Manufacturer
    Microgenics Corp

Manufacturer

Microgenics Corp
  • Manufacturer Address
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA