Events

Recall of Device Recall Pathromtin SL.

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
    28607
  • Event Risk Class
    Class 3
  • Event Number
    Z-0773-04
  • Event Initiated Date
    2004-03-01
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32220
  • 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
    Activated Partial Thromboplastin - Product Code GFO
  • Reason
    Cloudy appearance or precipitate.
  • Action
    The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.

Device

Device Recall Pathromtin SL.
  • Model / Serial
    Lot numbers 523785, 523785A, 523785B, and 523787
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
  • Product Description
    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
  • Source
    USFDA