Recall Z-1412-2021— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-1412-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-18

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2021-02-18, terminated 2022-02-24. It names one FDA 510(k) clearance: K100464. Product: ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit. Reason: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result.

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-18
Terminated: 2022-02-24
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONWako Chemicals USA, Inc.·cleared 2011-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

¿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

Data sourced from openFDA. This site is unofficial and independent of the FDA.