Z-1409-06

Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA...

Name: Z-1409-06 Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA...
Creator: Wako Chemicals, USA Inc
Published: 2006-07-06
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-07-06 / Terminated / root cause: manufacturing process

FDA source

Wako Chemicals, USA Inc began a recall of Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237... on 2006-07-06. The reason FDA records is "Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value". 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-1409-06
Status: Terminated
Initiated: 2006-07-06
Posted: 2006-08-25
Terminated: 2006-09-14
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
Product code: MMY Lipoprotein, Low Density, Removal
Reason for recall: Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product.
Quantity in commerce: 136 kits
Distribution: The product was sold to one distributor and direct medical accounts Nationwide.
Product codes and lots: Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06

Product code MMY

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)