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Wako Chemicals USA, Inc.

United States(FDA 510(k) applicant) Last updated 23 May 2026

Devices
124
Registries
FDA 510(k)
FDA recalls
3

Catalogue124

Page 1 of 3

Showing 1-50 of 124

FDA recalls3

Device pages show only the recalls that name the device or its 510(k)/PMA.

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.

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.

  • 2007

    • 30 Mar 2007 Z-1071-2007 Unclassified (pre-2012) Terminated Diagnostic reagent for clinical laboratory testing was incorrectly labeled.

  • 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.

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Wako Chemicals USA, Inc. have in the registry?

The registry currently lists 124 devices for Wako Chemicals USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wako Chemicals USA, Inc.'s devices?

Among its 50 most recently registered devices, Wako Chemicals USA, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Wako Chemicals USA, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Wako Chemicals USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Wako Chemicals USA, Inc.?

FDA recall records list 3 recalls initiated by Wako Chemicals USA, Inc., the most recent initiated on 2012-01-30. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Wako Chemicals USA, Inc. in the registry?

The most recently registered devices listed for Wako Chemicals USA, Inc. include WAKO DIRECT BILIRUBIN V, WAKO AUTOKIT CH50, WAKO TOTAL BILIRUBIN V and WAKO NEFA LINEARITY SET.

Generated automatically from registry data and not verified by a human reviewer.

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