Events

Recall of Device Recall Siemens ADVIA Centaur Systems 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
    76285
  • Event Risk Class
    Class 2
  • Event Number
    Z-1254-2017
  • Event Initiated Date
    2017-01-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152664
  • 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
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • Reason
    Siemens healthcare diagnostics has confirmed a negative bias for advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems. in addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected. customers may continue to use calibrator a kit lots ending in 90 for the advia centaur systems ft3, t3, t4 and tup assays.
  • Action
    Siemens issued Urgent Medical Device Recall (UMDR) sent to Siemens Healthcare Diagnostics customers in the United States on January 10, 2017 to be delivered to customers on January 11, 2017. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on January 10, 2017. The customer distribution included all customers that have received ADVIA Centaur Systems Calibrator A kit lots ending in 90 and ADVIA Centaur FT4 ReadyPacks. These notices inform the customer a negative bias has been confirmed for the ADVIA Centaur FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. ADVIA Centaur FT4 assay customers using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems were directed to discontinue the use of Calibrator A kit lots ending in 90 and instead use Calibrator A kit lots ending in 91 and above to calibrate the FT4 assay.

Device

Device Recall Siemens ADVIA Centaur Systems Calibrator A
  • Model / Serial
    Lot Numbers: 07995A90 08451A90 16035A90 32420A90 43871A90 59675A90 62739A90  Exp. Date: 2017/07/24
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam
  • Product Description
    Siemens ADVIA Centaur Systems Calibrator A Kits, || Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) || Cat No. 04800840, SMN 10285905 (6 pack - REF)
  • 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