# FDA recall Z-1412-2021

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2021-02-18.

## Product

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

## Reason for recall

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

## Distribution

CA, LA, MN, NC, UT, WI

## Key facts

- **Recall number:** Z-1412-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-18
- **Report date:** 2021-04-21
- **Termination date:** 2022-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2021

## Citation

> AI Analytics. FDA recall Z-1412-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1412-2021. Source: US FDA. Licensed CC0.

---

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