Events

Recall of Device Recall BCS(R) Behring Coagulation 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
    61768
  • Event Risk Class
    Class 2
  • Event Number
    Z-1867-2012
  • Event Initiated Date
    2010-12-01
  • Event Date Posted
    2012-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108994
  • 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
    Firm has confirmed that if the cleaner scs vial becomes empty after processing a test for antithrombin assay using the innovance(r) antithrombin kit, and the test immediately following is an aptt based clotting assay several results may be shortened.
  • Action
    An Urgent Field Safety Notice dated December 2010 was issued to all BCS(R) System owners. Firm conducted a voluntary field corrective action to notify BCS(R) System owners and to install a software "patch" to resolve the issue. Until the software patch was installed on the BCS(R) System, customers were instructed in the Safety Notice that "the potential issue of carryover can be avoided if the Cleaner SCS vial is kept filled and not allowrd to run empty."

Device

Device Recall BCS(R) Behring Coagulation System
  • Model / Serial
    Device catalog No. OVIO03 (not lot specific)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including the states of: AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of: Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.
  • Product Description
    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 || Product Usage: || Multipurpose system for In Vitro coagulation studies
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA