FDA-Device2013-08-07Class II
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.
Wako Life Sciences, Inc.
Hazard
Product fails to meet the accuracy at the low end of the measuring range.
Sold states
Distribution to CA, GA, MN, NC, UT and the District of Columbia.
Affected count
36 cartridges -100 tests per cartridge
Manufactured in
1025 Terra Bella Ave, N/A, Mountain View, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1831-2013Don't want to check this manually?
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