FDA-Device2018-11-28Class II
Tosoh AIA-900 immunoassay Analyzer
Tosoh Bioscience Inc
Hazard
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Sold states
Distributed to accounts in GA and NY.
Affected count
3
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
Tosoh AIA-900 immunoassay Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2019Don't want to check this manually?
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