Events

Recall of Device Recall BCS XP System

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
    73099
  • Event Risk Class
    Class 2
  • Event Number
    Z-0825-2016
  • Event Initiated Date
    2016-01-14
  • Event Date Posted
    2016-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143087
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Reason
    False short clotting times for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false low pt inr values. these false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. the result was not flagged by the existing check algorithms.
  • Action
    Urgent Medical Device Correction Letter (dated 1/12/2016) was sent to US consignees via FedEx on 1/14/2016 and to foreign consignees (distribution is determined at country level). The letter re-emphasizes the importance of checking the interference levels given in the respective Application Sheets of the BCS and BCS XP systems. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall BCS XP System
  • Model / Serial
    All serial numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.
  • Product Description
    BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA