FDA-Device2020-07-01Class II
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Tosoh Bioscience Inc
Hazard
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
Sold states
Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
Affected count
529
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2020Don't want to check this manually?
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