Company: Tosoh Bioscience Inc
Date of Enforcement Report: 3/11/2020
Class II

PRODUCT

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

• Recall Number: Z-1420-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Tosoh Bioscience Inc on 1/10/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

12

DISTRIBUTION

US Nationwide and International