Events

Recall of Device Recall Siemens Coagulation FIX Deficient PlasmaClotting Factor VIIIIXXIXII Deficient Plasma

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    71267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1713-2015
  • Event Initiated Date
    2015-05-11
  • Event Date Posted
    2015-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137172
  • 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
    Plasma, coagulation factor deficient - Product Code GJT
  • Reason
    Discrepancies for siemens bcs / bcs xp with dilution studies; erroneously high factor ix results at the lower end of the measuring range.
  • Action
    An Urgent Medical Device Recall notice, dated May 2015, was sent to affected customers to inform them about the issue and associated risks. Customers were asked to discontinue use, distribute this information to all appropriate personnel, and to complete and fax back to Siemens the Effectiveness Check form.

Device

Device Recall Siemens Coagulation FIX Deficient PlasmaClotting Factor VIIIIXXIXII Deficient Plasma
  • Model / Serial
    10454742 10454729 10461894 10470625
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.
  • Product Description
    Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. || In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA