FDA-Device2018-11-21Class II
AIA-900 Analyzer, Product code 022930, 022930R
Tosoh Bioscience Inc
Hazard
Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
Sold states
Distributed nationwide. Foreign distribution to Canada and Latin America.
Affected count
393
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
AIA-900 Analyzer, Product code 022930, 022930R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2019Don't want to check this manually?
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