Recall Z-1831-2013
Wako Life Sciences, Inc. · initiated April 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: TG340, Exp. 11/30/13
Reason for recall
Product fails to meet the accuracy at the low end of the measuring range.
FDA-determined cause: Material/Component Contamination
Action taken
Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to liver@wakousa.com or call 443-535-0702.
Details
- Recall number
- Z-1831-2013
- Initiated
- April 30, 2013
- Posted by FDA
- July 30, 2013
- Terminated
- August 19, 2013
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Quantity
- 36 cartridges -100 tests per cartridge
- Distribution
- Distribution to CA, GA, MN, NC, UT and the District of Columbia.
- Recalling firm
- Wako Life Sciences, Inc., Mountain View, CA