Events

Recall of Device Recall ADVIA Centaur Calibrator A

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
    65626
  • Event Risk Class
    Class 3
  • Event Number
    Z-1970-2013
  • Event Initiated Date
    2013-06-28
  • Event Date Posted
    2013-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119762
  • 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
    Calibrator, primary - Product Code JIS
  • Reason
    Calibrator a lot ca77 is under-recovering to the assigned target for the advia centaur total t4 assay.
  • Action
    An Urgent Medical Device Correction (UDMC) was sent to all affected Siemens Healthcare Diagnostic customers in the United States on June 28, 2013 via FedEx. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on June 27, 2013. FedEx Return Receipts will be used to confirm that the customers received the UMDC. If confirmation of receipt by any customer cannot be verified through a return receipt, a Siemens Technical Solutions Center Representative will contact those customers by telephone to ensure that they received the Urgent Medical Device Correction and completed the required actions. These notices inform the customer that they should discontinue the use of Calibrator A, lots ending in 77, for use with the ADVIA Centaur Systems T4 assay. Customers are informed that they may continue to use Calibrator A lot CA77 with the other assays FT3, FT4, Total T3, T-Uptake. For questions or additional information contact your local Technical Support Provider or Distributor.

Device

Device Recall ADVIA Centaur Calibrator A
  • Model / Serial
    REF 10285904 (6 pack): 89983A77 16 Jul 2013, 90669A77 16 Jul 2013; REF 10285905 (6 pack - REF); 90705A77 16 Jul 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Nationwide including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, VA, VT, and WV and the countries of Slovakia, Germany, Turkey, TW, HK, CH, TH, BR, CN, SG, and ZA.
  • Product Description
    ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). || For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
  • 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