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U.S. Department of Health and Human Services

Class 2 Device Recall uTASWako DCP

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 Class 2 Recall
uTASWako DCP
see related information
Date Posted July 30, 2013
Recall Status1 Terminated on August 19, 2013
Recall Number Z-1831-2013
Recall Event ID 65084
Premarket Notification
510(K) Number
K100464 
Product Classification Albumin, Antigen, Antiserum, Control - Product Code DCF
Product uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Code Information TG340, Exp. 11/30/13
Recalling Firm/
Manufacturer
Wako Life Sciences, Inc.
1025 Terra Bella Ave
Mountain View, California 94043-1829
For Additional Information Contact Martha Murari, Ph.D., RAC
877-714-1924
Manufacturer Reason
for Recall
Product fails to meet the accuracy at the low end of the measuring range.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to liver@wakousa.com or call 443-535-0702.
Quantity in Commerce 36 cartridges -100 tests per cartridge
Distribution Distribution to CA, GA, MN, NC, UT and the District of Columbia.
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 = DCF and Original Applicant = WAKO CHEMICALS USA, INC.
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