Tosoh Bioscience Inc recalls AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diag…

Recall date

August 23, 2018

Source

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

Recall number

Z-0559-2019

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.

Why it was recalled

The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.

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-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.