Z-0940-04

K-Assay Lp(a) Control

Name: Z-0940-04 K-Assay Lp(a) Control
Creator: Kamiya Biomedical Company
Published: 2004-03-29
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2004-03-29 / Terminated

FDA source

Kamiya Biomedical Company began a recall of K-Assay Lp(a) Control on 2004-03-29. The reason FDA records is "Assay result not consistent with the assigned control value". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0940-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2004-07-09
Recalling firm: Kamiya Biomedical Company, LLC
Product: K-Assay Lp(a) Control
Product code: DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Reason for recall: Assay result not consistent with the assigned control value
FDA root cause: Other
Action: On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests return of the product.
Quantity in commerce: 16
Distribution: The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.
Product codes and lots: Lot D407

Product code DFC

K023853Class IIK-Assay Lp(a) ControlsKamiya Biomedical Co. / cleared 2002-12-13

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)