Class 3 Device Recall KAssay

• Date Initiated by Firm: March 29, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 09, 2004
• Recall Number: Z-0940-04
• Recall Event ID: 28825
• 510(K)Number: K023853
• Product Classification: Lipoprotein, Low-Density, Antigen, Antiserum, Control - Product Code DFC
• Product: K-Assay Lp(a) Control
• Code Information: Lot D407
• FEI Number: 2084025
• Recalling Firm/ Manufacturer: Kamiya Biomedical Company; 910 Industry Dr; Seattle WA 98188-3412
• For Additional Information Contact: Colin Getty; 206-575-8068
• Manufacturer Reason for Recall: Assay result not consistent with the assigned control value
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DFC