# FDA recall Z-0475-2019

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-09-28.

## Product

AIA-2000 Analyzer, Model Nos.  AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

## Reason for recall

There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.

## Distribution

US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.

## Key facts

- **Recall number:** Z-0475-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2018-11-28
- **Termination date:** 2020-05-29

- **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-0475-2019

## Citation

> AI Analytics. FDA recall Z-0475-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0475-2019. Source: US FDA. Licensed CC0.

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