Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1831-2013

U.S. FDA — Device Enforcement · United States · 2013-04-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1831-2013
Date of alert: 2013-04-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Wako Life Sciences, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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