Events

Recall of Device Recall Staclot LA 20

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
    35946
  • Event Risk Class
    Class 2
  • Event Number
    Z-1441-06
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47247
  • 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
    LA Assay - Product Code GFO
  • Reason
    Decrease in sensitivity ; this could result in a false negative result for patients with weak to moderate lupus anticoagulants.
  • Action
    Recall notification letters were sent out via first class mail on July 18, 2006.

Device

Device Recall Staclot LA 20
  • Model / Serial
    Lot 050947D --exp. April 2007; Lot 051527A -- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007; Lot 051527D -- exp. June 2007.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

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