Wako Life Sciences, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1831-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 30, 2013

Date Posted: August 7, 2013

Recall Number: Z-1831-2013

Event ID: 65084

Reason for Recall:

Product fails to meet the accuracy at the low end of the measuring range.

Status: Terminated

Product Quantity: 36 cartridges -100 tests per cartridge

Code Information:

TG340, Exp. 11/30/13

Distribution Pattern:

Distribution to CA, GA, MN, NC, UT and the District of Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated