Tosoh Bioscience Inc recalls AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Recall date

January 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1420-2020

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AIA-360 Automated Immunoassay Analyzer, Product Code 019945