Class 2 Device Recall BioGenex

• Date Initiated by Firm: June 02, 2006
• Date Posted: August 29, 2006
• Recall Status: Terminated on November 17, 2006
• Recall Number: Z-1439-06
• Recall Event ID: 35614
• Product Classification: Hepatitis B Virus Surface Antigen - Product Code MVU
• Product: BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583
• Code Information: Lot Numbers: AM3640305, AM3640404, AM3640406, AM3640505, AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005
• FEI Number: 2936532
• Recalling Firm/ Manufacturer: Biogenex Laboratories; 4600 Norris Canyon Road; San Ramon CA 94583-1320
• Manufacturer Reason for Recall: Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific
• FDA Determined Cause: Other
• Action: On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.
• Quantity in Commerce: 96 units for both Recall Z-1438/1439-06
• Distribution: Nationwide
• 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.