Events

Recall of Device Recall Xmatrx FISH Automated Staining 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
    46903
  • Event Risk Class
    Class 2
  • Event Number
    Z-1471-2008
  • Event Initiated Date
    2008-01-24
  • Event Date Posted
    2008-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68451
  • 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
    Automated slide staining system - Product Code KEY
  • Reason
    Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
  • Action
    The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.

Device

Device Recall Xmatrx FISH Automated Staining System
  • Model / Serial
    Serial numbers AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237. These serial numbers encompass ALL products distributed.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to a single distributor, which further distributed the product.
  • Product Description
    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B
  • Manufacturer
    Biogenex Laboratories

Manufacturer

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