Events

Recall of PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., 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
    32494
  • Event Risk Class
    Class 2
  • Event Number
    Z-1419-05
  • Event Initiated Date
    2005-04-13
  • Event Date Posted
    2005-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40189
  • 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
    Test, Time, Partial Thromboplastin - Product Code GGW
  • Reason
    Variable clotting times observed with the ptt-la, lupus anticoagulant-sensitive aptt reagent.
  • Action
    On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.

Device

PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in...
  • Model / Serial
    Cat. No. 00599 Lot Number 041755 exp. 06/06.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
  • Product Description
    PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., 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