Class 3 Device Recall BioGenex

• Date Initiated by Firm: September 05, 2006
• Date Posted: September 23, 2006
• Recall Status: Terminated on November 17, 2006
• Recall Number: Z-1519-06
• Recall Event ID: 36259
• Product Classification: Anti-CD 45 antibody - Product Code NJT
• Product: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
• Code Information: Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
• FEI Number: 2936532
• Recalling Firm/ Manufacturer: Biogenex Laboratories; 4600 Norris Canyon Road; San Ramon CA 94583-1320
• Manufacturer Reason for Recall: Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
• FDA Determined Cause: Other
• Action: On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter.
• Quantity in Commerce: 13 vials.
• Distribution: Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
• 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.