Z-1377-2012

Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in...

Name: Z-1377-2012 Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in...
Creator: Wako Chemicals USA, Inc.
Published: 2012-01-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2012-01-30 / Terminated / root cause: design

FDA source

Wako Chemicals USA, Inc. began a recall of Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical... on 2012-01-30. The reason FDA records is "In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1377-2012
Status: Terminated
Initiated: 2012-01-30
Posted: 2012-04-06
Terminated: 2012-05-02
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
Product code: DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Reason for recall: In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
Root cause tag: design
FDA root cause: Device Design
Action: Wako Diagnostics notified its customers by telephone on January 26, 2012 and sent an Urgent Medical Device Recall letter dated January 30, 2012 to inform them of the product recall. The notifications identified the affected product, problem and actions to be taken. Consignees were requested to: 1) Complete and sign the attached Return Materials Authorization (RMA) Form to receive replacement material and 2) Package the recalled Product to be returned and send to the address listed on the RMA form. For questions call Technical Support Team at 1-877-714-1924.
Quantity in commerce: 10 kits
Distribution: The product had been sold to 2 customers in the US.
Product codes and lots: Lot No.: DJ427, Exp 08-31-12

Product code DFC

K981446Class IIWako Autokit Lp(a)Wako Chemicals USA, Inc. / cleared 1999-03-09

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)