# FDA recall Z-2827-2018

> **Tosoh Bioscience Inc** · Class III · device recall initiated 2018-06-05.

## Product

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD  Part Number: 997027    CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.

## Reason for recall

Distribution of unapproved product labeling

## Distribution

US Distribution to states of:  FL, MA, MT, OK, OR and WI.

## Key facts

- **Recall number:** Z-2827-2018
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-05
- **Report date:** 2018-08-22
- **Termination date:** 2020-04-03

- **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-2827-2018

## Citation

> AI Analytics. FDA recall Z-2827-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2827-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*