Z-1439-06

BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is...

Name: Z-1439-06 BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is...
Creator: Biogenex Laboratories
Published: 2006-06-02
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2006-06-02 / Terminated / root cause: labeling and UDI

FDA source

Biogenex Laboratories began a recall of BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon... on 2006-06-02. The reason FDA records is "Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1439-06
Status: Terminated
Initiated: 2006-06-02
Posted: 2006-08-29
Terminated: 2006-11-17
Recalling firm: Biogenex Laboratories, Inc.
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
Product code: MVU Reagents, Specific, Analyte
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
Root cause tag: labeling and UDI
FDA root 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
Product codes and lots: Lot Numbers: AM3640305, AM3640404, AM3640406, AM3640505, AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)