Events

Recall of Device Recall Siemens

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
    65562
  • Event Risk Class
    Class 2
  • Event Number
    Z-1960-2014
  • Event Initiated Date
    2013-06-25
  • Event Date Posted
    2014-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119579
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    Advia centaur homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the instructions for use (ifu).
  • Action
    Siemens Healthcare sent an Urgent Field Safety Notice that was sent to all affected Siemens Healthcare Diagnostics customers in the United States on June 25, 2013. The Urgent Field Safety Notice was sent out for distribution to all customers outside the United States on June 24, 2013. These notices inform the customer that the 1:10 diluted patient recovery is lower than reported in the Instructions for Use (IFU). Customers should discontinue use of both manual and on board 1:10 dilutions of samples with the ADVIA Centaur HCY assay. Customers can continue to use a manual or on board 1 :2 dilution for samples with results outside of the assay range. Siemens has confirmed the performance at the 1 :2 dilution level meets the IFU ranges. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. For further questions please call (508) 668-5000.

Device

Device Recall Siemens
  • Model / Serial
    Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
  • Product Description
    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA