Class 3 Device Recall KASSAY Alpha1 Microglobulin Reagent

• Date Initiated by Firm: September 17, 2008
• Date Posted: January 19, 2011
• Recall Status: Terminated on January 20, 2011
• Recall Number: Z-0923-2011
• Recall Event ID: 50074
• Product Classification: Alpha-1 microglobulin, antigen, antiserum, control - Product Code MGA
• Product: K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. ; ; The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
• Code Information: Lot number 418041, catalog number KAI-056.
• Recalling Firm/ Manufacturer: Kamiya Biomedical Company, LLC; 12779 Gateway Dr S; Tukwila WA 98168-3308
• For Additional Information Contact: 206-575-8068
• Manufacturer Reason for Recall: Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
• FDA Determined Cause: Employee error
• Action: Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.
• Quantity in Commerce: 5 kits
• Distribution: Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
• 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.