Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

uTASWako DCP Recalled by Wako Life Sciences, Inc. Due to Product fails to meet the accuracy at the...

Date: April 30, 2013
Company: Wako Life Sciences, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Wako Life Sciences, Inc. directly.

Affected Products

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.

Quantity: 36 cartridges -100 tests per cartridge

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 5 states: CA, GA, MN, NC, UT

Affected (5 states)Not affected

About Wako Life Sciences, Inc.

Wako Life Sciences, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report