Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: Recalled by Tosoh Bioscience Inc Due to Distribution of unapproved product labeling

Date: June 5, 2018
Company: Tosoh Bioscience Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.

Affected Products

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.

Quantity: 9 CDS

Why Was This Recalled?

Distribution of unapproved product labeling

Where Was This Sold?

This product was distributed to 6 states: FL, MA, MT, OK, OR, WI

Affected (6 states)Not affected

About Tosoh Bioscience Inc

Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report