Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2021 - (Recall #: Z-1412-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 18, 2021

Date Posted: April 21, 2021

Recall Number: Z-1412-2021

Event ID: 87507

Reason for Recall:

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

Status: Terminated

Product Quantity: 496 units

Code Information:

Lot Number: EQ194 Exp. Date: 05/31/2022

Distribution Pattern:

CA, LA, MN, NC, UT, WI

Voluntary or Mandated:

Voluntary: Firm initiated