Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AIA-360 Automated Immunoassay Analyzer Recalled by Tosoh Bioscience Inc Due to A display screen software issue on the analyzer...

Date: January 10, 2020
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

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Quantity: 12

Why Was This Recalled?

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

Where Was This Sold?

This product was distributed to 5 states: AZ, NE, NJ, NY, WA

Affected (5 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