Events

Recall of Dade Behring

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

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
    36600
  • Event Risk Class
    Class 2
  • Event Number
    Z-0247-2007
  • Event Date Posted
    2006-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48972
  • 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
    in vitro diagnostic - Product Code LIE
  • Reason
    Product does not meet performance specifications through its standardized inocula for microscan dried gram-negative and gram-positive overnight panel testing.
  • Action
    On 9/27/06, the firm initiated the recall and its notification was via phone calls and letters (FedEx''ed) explaining the reason for the recall and requesting the product be discarded.

Device

Dade Behring
  • Model / Serial
    Lot Numbers: 20071127, 20071128
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, China, and Germany.
  • Product Description
    Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;
  • Manufacturer
    Dade Behring, Inc.

Manufacturer

Dade Behring, Inc.
  • Manufacturer Address
    Dade Behring, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Source
    USFDA