FDA Medical Device Recalls (openFDA)
Biogenex Laboratories: 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
- Recall number
- Z-1439-06
- Recalling firm
- Biogenex Laboratories
- 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
- Status
- Terminated
- Initiated
- 2006-06-02
- Posted
- 2006-08-29
- Terminated
- 2006-11-17
- Reason
- 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
- Other
- Action
- On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.
- Quantity
- 96 units for both Recall Z-1438/1439-06
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: AM3640305, AM3640404, AM3640406, AM3640505, AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2936532
- Firm city
- San Ramon
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28