Wako uTAS DCP Reagent Cartridges Recalled for Accuracy Failures
Wako Life Sciences is recalling uTAS DCP reagent cartridges because they fail to meet accuracy standards at the low end of the measuring range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a failure to meet accuracy standards without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Wako Life Sciences, Inc. is recalling uTAS DCP reagent cartridges, Lot TG340 2013.11, REF 995-60701. The product is a single reagent cartridge used on an automated system for assays performed on a single disposable chip using microfluidic electrophoretic separation. The recall involves 36 cartridges, with 100 tests per cartridge.
The recall was initiated because the product fails to meet the accuracy at the low end of the measuring range. The agency has classified this as a Class II recall.
The affected product was distributed to California, Georgia, Minnesota, North Carolina, Utah, and the District of Columbia. Users of the product should stop using the affected cartridges and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Wako Life Sciences, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- TG340
- Exp. 11/30/13
Distribution
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