Z-1412-2021Class II

TASWako Chip Cassette is part of the Wako TASWako i30 kit

Name: Z-1412-2021 TASWako Chip Cassette is part of the Wako TASWako i30 kit
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2021-02-18
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-02-18 / Terminated

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of TASWako Chip Cassette is part of the Wako TASWako i30 kit on 2021-02-18. FDA classified it as Class II and gives the reason as "Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1412-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-18
Posted: 2021-04-13
Terminated: 2022-02-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: TASWako Chip Cassette is part of the Wako TASWako i30 kit
Product code: NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Reason for recall: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
FDA root cause: Under Investigation by firm
Action: Fujifilm issued Consignee notifications via courier delivery and electronic mail on February 18, 2021. The letter states reason for recall, health risk and action to take: FUJIFILM is recommending that you immediately cease use of any Cavity #2 chips in Lot EQ194 and return the product to FUJIFILM. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken: Upon receipt of the Field Action Verification Form, FUJIFILM will provide replacement chip cassette boxes (each containing 5 x 20 chips) from a different lot. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at [email protected], if you have any further questions regarding this field action.
Quantity in commerce: 496 units
Distribution: CA, LA, MN, NC, UT, WI
Product codes and lots: Lot Number: EQ194 Exp. Date: 05/31/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1412-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1412-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-12

Product code NSF

K100464Class IIUtaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. / cleared 2011-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)