Events

Recall of Device Recall BioGenex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biogenex Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35614
  • Event Risk Class
    Class 2
  • Event Number
    Z-1438-06
  • Event Initiated Date
    2006-06-02
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46471
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Hepatitis B Virus Core Antigen - Product Code MVU
  • 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 reagent (asr).
  • Action
    On 6/5/06, via letter explaining the reason for the recall and requesting the product be disposed.

Device

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

Manufacturer

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