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U.S. Department of Health and Human Services

Class 2 Device Recall BioGenex

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  Class 2 Device Recall BioGenex see related information
Date Initiated by Firm June 02, 2006
Date Posted August 29, 2006
Recall Status1 Terminated 3 on November 17, 2006
Recall Number Z-1438-06
Recall Event ID 35614
Product Classification Hepatitis B Virus Core Antigen - Product Code MVU
Product BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP,
Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583
Code Information Lot Numbers:  AR0820904  PU0820204,  PU0820305,  PU0820803F,  PU0820804
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 Reagent (ASR).
FDA Determined
Cause 2		 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 Recalls 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.
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