Events

Recall of BioGenex Super Sensitive LinkLabel IHC Detection System

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
    36514
  • Event Risk Class
    Class 3
  • Event Number
    Z-0217-2007
  • Event Initiated Date
    2006-10-03
  • Event Date Posted
    2006-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48784
  • 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
    ICH Detection Kit - Product Code NJT
  • Reason
    Mislabeling: the product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 ml alk phos label' which should read '1 x 100 ml hrp label'. a second, smaller label, incorrectly reads "rtu multilink hpr/aec" which should be labeled as "rtu multilink hpr". the reagent vials in the box are correctly labeled.
  • Action
    The firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.

Device

BioGenex Super Sensitive LinkLabel IHC Detection System
  • Model / Serial
    Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
  • Product Description
    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
  • Manufacturer
    Biogenex Laboratories

Manufacturer

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