Recall Z-1831-2013— Wako Life Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by Wako Life Sciences, Inc., initiated 2013-04-30, terminated 2013-08-19. It names one FDA 510(k) clearance: K100464. 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.. Reason: Product fails to meet the accuracy at the low end of the measuring range..
- Recalling firm
- Wako Life Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-30
- Terminated
- 2013-08-19
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.