Z-1831-2013Class II

uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome...

Name: Z-1831-2013 uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome...
Creator: Wako Life Sciences, Inc.
Published: 2013-04-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2013-04-30 / Terminated / root cause: manufacturing process

FDA source

Wako Life Sciences, Inc. began a recall of uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako... on 2013-04-30. FDA classified it as Class II and gives the reason as "Product fails to meet the accuracy at the low end of the measuring range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1831-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-30
Posted: 2013-07-30
Terminated: 2013-08-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
Product code: DCF Albumin, Antigen, Antiserum, Control
Reason for recall: Product fails to meet the accuracy at the low end of the measuring range.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Wako Life Sciences, Inc. sent an email and issued a Recall Notice letter via FED EX on April 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue the use of these kits, fill out the attached RMA form, and return unused kits using Wako's FedEx account (provided on RMA form). Partially used reagent cartridges should be disposed of according to your local and state requirements. Wako Life Sciences will relplace your existing stock of uTASWako DCP kits with kits from a different log number that has been tested and has shown to not be affected. If you have any questions regarding the Recall, please submit your inquiries to [email protected] or call 443-535-0702.
Quantity in commerce: 36 cartridges -100 tests per cartridge
Distribution: Distribution to CA, GA, MN, NC, UT and the District of Columbia.
Product codes and lots: TG340, Exp. 11/30/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-30

Product code DCF

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)