Events

Recall of 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
    36259
  • Event Risk Class
    Class 3
  • Event Number
    Z-1519-06
  • Event Initiated Date
    2006-09-05
  • Event Date Posted
    2006-09-23
  • 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=48267
  • 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
    Anti-CD 45 antibody - Product Code NJT
  • Reason
    Mislabeling: anti-cd45 cocktail antibody mislabeled as ki-67.
  • Action
    On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter.

Device

BioGenex
  • Model / Serial
    Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
  • Product Description
    Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
  • Manufacturer
    Biogenex Laboratories

Manufacturer

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