Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0559-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 23, 2018

Date Posted: December 12, 2018

Recall Number: Z-0559-2019

Event ID: 81054

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1228

Code Information:

Change to labeling affects all devices.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated