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Tosoh Bioscience Inc recalls AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Recalled July 1, 2020 · FDA recall Z-2423-2020 · Tosoh Bioscience
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. · FDA Class II
Units
529
Sold at
Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
Description
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.
Product
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →