# FDA recall Z-0491-2018

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2017-06-11.

## Product

Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930.  Product Usage:  The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

## Reason for recall

This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

## Distribution

Worldwide Distribution - U.S. Nationwide - Latin America

## Key facts

- **Recall number:** Z-0491-2018
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-11
- **Report date:** 2018-02-07
- **Termination date:** 2019-12-31

- **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-0491-2018

## Citation

> AI Analytics. FDA recall Z-0491-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0491-2018. Source: US FDA. Licensed CC0.

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