Events

Recall of Device Recall Siemens Factor VIII Chromogenic Assay

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
    72752
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-2016
  • Event Initiated Date
    2015-11-19
  • Event Date Posted
    2015-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142132
  • 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
    Test, qualitative and quantitative factor deficiency - Product Code GGP
  • Reason
    Factor viii chromogenic assay lot 44637 is showing an increased occurrence of irregular curves when used for measurement on sysmex ca-1500, ca-7000, cs-2000i, cs-2100i, cs-5100 systems. this could lead, under certain circumstances, to an erroneously increased result with a factor viii chromogenic assay.
  • Action
    Siemens sent an Urgent Medical Device Correction Letter dated November 19, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by Customers: If you are using the affected lot of Factor VIII Chromogenic Assay on a Sysmex CA-1500 or CA-7000 System, please discontinue use. - Due to a different detection principle, the use on BCS and BCS XP is not affected and you can continue using the product on BCS / BCS XP. - Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. - Review your inventory of this product to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Corrective Action: The Factor VIII Chromogenic Assay Lot Number 44637 kits were placed on product hold on August 19, 2015, at the Siemens Distribution Centers. For further questions, please call ( 914) 524 - 2495.

Device

Device Recall Siemens Factor VIII Chromogenic Assay
  • Model / Serial
    Lot Number 44637, exp. 2016-11-30
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.
  • Product Description
    Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
  • 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