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Wako Chemicals USA, Inc.

United StatesFDA applicant, unverified

Devices
124
FDA recalls
3

What Wako Chemicals USA, Inc. makes

Wako Chemicals USA, Inc. manufactures biochemical assay kits and calibrators for laboratory use, including standards for total bilirubin, albumin, lipase, C-reactive protein (CRP), transferrin, and phospholipids. Their portfolio also includes automated biochemical analyzer systems (WAK0-20R & 30R) and specialized reagents like NEFA linearity sets and iron (L-Type Fe) calibrators.

The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their assays and calibrators are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Wako Chemicals USA, Inc., the earliest on 2006-07-06 and the most recent on 2012-01-30. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 30 Jan 2012 Z-1377-2012 Not yet classified Terminated In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease. Distribution: The product had been sold to 2 customers in the US. Submission number: K981446

  • 2007

    • 30 Mar 2007 Z-1071-2007 Unclassified (pre-2012) Terminated Diagnostic reagent for clinical laboratory testing was incorrectly labeled. Distribution: Worldwide, including USA, Germany and Canada.

  • 2006

    • 6 Jul 2006 Z-1409-06 Unclassified (pre-2012) Terminated Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value. Distribution: The product was sold to one distributor and direct medical accounts Nationwide. Submission number: K981446