Device 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.
Z-1831-2013
Product summary
- Event
- Event 65084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 cartridges -100 tests per cartridge
- Official record key
device-enforcement:Z-1831-2013
Official wording
Reason: Product fails to meet the accuracy at the low end of the measuring range.
Code information: TG340, Exp. 11/30/13
Distribution pattern: Distribution to CA, GA, MN, NC, UT and the District of Columbia.
Derived failure modes
-
Unknown
Product fails to meet the accuracy at the low end of the measuring range.