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U.S. Department of Health and Human Services

Class 2 Device Recall CEDIA Tobramycin II Assay

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 Class 2 Recall
CEDIA Tobramycin II Assay
see related information
Date Posted December 16, 2013
Recall Status1 Terminated on February 03, 2014
Recall Number Z-0513-2014
Recall Event ID 66626
Premarket Notification
510(K) Number
K912143 
Product Classification Fluorescence Polarization Immunoassay, Tobramycin - Product Code LFW
Product 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.
Code Information Lot Number: 60169764
Recalling Firm/
Manufacturer
Microgenics Corp
46360 Fremont Blvd
Fremont, California 94538-6406
For Additional Information Contact Mark H. Smith
510-979-5000
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Quantity in Commerce 370 units
Distribution Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LFW and Original Applicant = MICROGENICS CORP.
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