Class 3 Device Recall IgG FITC Conjugate

• Date Initiated by Firm: January 23, 2013
• Date Posted: June 05, 2013
• Recall Status: Terminated on May 05, 2015
• Recall Number: Z-1479-2013
• Recall Event ID: 64164
• 510(K)Number: K926066
• Product Classification: Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
• Product: Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
• Code Information: Product Code: CCG-9972; Lot: CCG-0281
• Recalling Firm/ Manufacturer: Bion Enterprises Ltd; 455 State St; Suite 100; Des Plaines IL 60016-2204
• For Additional Information Contact: Judy Rasmussen; 847-544-5044
• Manufacturer Reason for Recall: Affected products have a labeled expiration date of one year too long.
• FDA Determined Cause: Error in labeling
• Action: MBL Bion sent an Urgent Product Recall letter dated January 28, 2013 to all affected customers via email. The letter identified the affected product, problem and actions to be taken. Customers were requested to destroy the affected product and to notify Bion of the number of units consumed and destroyed. For questions call 847-544-5044.
• Quantity in Commerce: 504 units
• Distribution: Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)
• 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 = LJY