FDA-Device2020-03-11Class II
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Tosoh Bioscience Inc
Hazard
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.
Sold states
Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
Affected count
12
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1420-2020Don't want to check this manually?
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