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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65084
Product Type Devices
Status Ongoing
Recalling Firm Wako Life Sciences, Inc.
City Mountain View
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distribution to CA, GA, MN, NC, UT and the District of Columbia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. TG340, Exp. 11/30/13 Class II Product fails to meet the accuracy at the low end of the measuring range. 36 cartridges -100 tests per cartridge Z-1831-2013
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