Z-1831-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2013
- Initiation Date
- April 30, 2013
- Termination Date
- August 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 cartridges -100 tests per cartridge
Product Description
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.
Reason for Recall
Product fails to meet the accuracy at the low end of the measuring range.
Distribution Pattern
Distribution to CA, GA, MN, NC, UT and the District of Columbia.
Code Information
TG340, Exp. 11/30/13