Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to Potentially defective Chip Cassette units, when used for...

Date: February 18, 2021
Company: Fujifilm Medical Systems U.S.A., Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.

Affected Products

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

Quantity: 496 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 6 states: CA, LA, MN, NC, UT, WI

Affected (6 states)Not affected

About Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report