Devices

Device Recall BioGenex

Model / Serial
Lot Numbers: AM3640305, AM3640404, AM3640406, AM3640505, AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide
Product Description
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
Manufacturer
Biogenex Laboratories
1 Event
- Recall of Device Recall BioGenex

Manufacturer

Biogenex Laboratories

Manufacturer Address
Biogenex Laboratories, 4600 Norris Canyon Road, San Ramon CA 94583-1320
Source
USFDA

One device with a similar name

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Device Recall BioGenex

Model / Serial
Lot Numbers: AR0820904 PU0820204, PU0820305, PU0820803F, PU0820804
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide
Product Description
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
Manufacturer
Biogenex Laboratories

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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