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.
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.
조치
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.
Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
제품 설명
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.