Reported Aug 7, 2013 · Terminated
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku…
Wako Life Sciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wako Life Sciences, Inc. · 1025 Terra Bella Ave · Mountain View, CA · 94043-1829
Is this the product you have?
- 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.
- Lot codes and dates
TG340Exp. 11/30/13
- Amount recalled
- 36 cartridges -100 tests per cartridge
Where it was sold
Why it was recalled
Product fails to meet the accuracy at the low end of the measuring range.
This product could cause temporary or reversible health problems — stop using it.
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