# FDA recall Z-0559-2019

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-08-23.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0559-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-23
- **Report date:** 2018-12-12
- **Termination date:** 2020-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0559-2019

## Citation

> AI Analytics. FDA recall Z-0559-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0559-2019. Source: US FDA. Licensed CC0.

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