Events

Recall of Device Recall Dade Fibrin(ogen) Degradation Products (FDP) Dectection Set

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
    32537
  • Event Risk Class
    Class 2
  • Event Number
    Z-1040-05
  • Event Initiated Date
    2005-06-21
  • Event Date Posted
    2005-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40291
  • 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
    Fibrin Split Products - Product Code GHH
  • Reason
    Positive control shows weak agglutination reaction.
  • Action
    The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.

Device

Device Recall Dade Fibrin(ogen) Degradation Products (FDP) Dectection Set
  • Model / Serial
    Lot number P152010 exp 4/30/06.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
  • Product Description
    Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA