Tosoh Bioscience Inc recalls AIA-900 Analyzer, Part no. 022930, UDI 04560189283992

Recall date

May 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2423-2020

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AIA-900 Analyzer, Part no. 022930, UDI 04560189283992