Events

Recall of FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. || The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. || Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostica Stago, 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
    29178
  • Event Risk Class
    Class 3
  • Event Number
    Z-1080-04
  • Event Initiated Date
    2002-12-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33267
  • 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
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
  • Reason
    The fdp plasma latex reagent (reagent vial 1) is more sensitive which may result in a weak agglutination at low concentration of fdps.
  • Action
    Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.

Device

FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen deg...
  • Model / Serial
    Lot 012823 Exp October 2003
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed the product 220 direct accounts which include hospitals, clinics, and clinical laboratories. There are 9 VA accounts.
  • Product Description
    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. || The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. || Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

Diagnostica Stago, Inc.
  • Manufacturer Address
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA