Recall Z-0559-2019— Tosoh Bioscience Inc

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-08-23, terminated 2020-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm

Tosoh Bioscience Inc

Classification

Class II

Status

Terminated

Initiated

2018-08-23

Terminated

2020-10-20

Firm location

Grove City, OH, United States

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