FDA Enforcement
Class II
Terminated
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.
Recall: Z-1831-2013
·
Reported August 7, 2013
Enforcement
- Recall Number
- Z-1831-2013
- Event ID
- 65084
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wako Life Sciences, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2013
- Initiation Date
- April 30, 2013
- Classification Date
- July 30, 2013
- Termination Date
- August 19, 2013
- Address
- 1025 Terra Bella Ave, N/A, Mountain View, CA, 94043-1829, United States
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
Product fails to meet the accuracy at the low end of the measuring range.
Code Info
TG340, Exp. 11/30/13
Distribution
Distribution to CA, GA, MN, NC, UT and the District of Columbia.
Quantity
36 cartridges -100 tests per cartridge