Biogenex Laboratories 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Biogenex Laboratories
Lot Codes / Batch Numbers
Lot Numbers: AR0820904 PU0820204, PU0820305, PU0820803F, PU0820804
Products Sold
Lot Numbers: AR0820904 PU0820204, PU0820305, PU0820803F, PU0820804
Biogenex Laboratories is recalling BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is d due to Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Sp. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026