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Tosoh Bioscience Inc recalls AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Recalled March 11, 2020 · FDA recall Z-1420-2020 · Tosoh Bioscience
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. · FDA Class II
Units
12
Sold at
Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
Description
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.
Product
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →