Events

Recall of Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH

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
    62897
  • Event Risk Class
    Class 3
  • Event Number
    Z-2410-2012
  • Event Initiated Date
    2012-08-07
  • Event Date Posted
    2012-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112142
  • 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
    Siemens Healthcare - Product Code CGJ
  • Reason
    Advia centaur prolactin assay and fsh, calibrator b fails the analytical sensitivity stated in the ifu for lots below 40.
  • Action
    Siemens Healthcare issued an Urgent Field Safety Notice letter dated August 2012 by e-mail to all affected Siemens Healthcare Diagnostics Branch offices on August 7, 2012. Customers were instructed to discontinue using the ADVIA Centaur Calibrator B lots 40 and below following their obtaining Calibrator 8 lot 41 or higher. Customers were asked to complete and fax-back the response form attached.

Device

Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH
  • Model / Serial
    US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254  79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577  78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130  Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
  • Product Description
    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B || US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) || OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) || Product Usage: || ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
  • 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