Events

Recall of Device Recall Assay for CA 27.29

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
    76766
  • Event Risk Class
    Class 2
  • Event Number
    Z-1749-2017
  • Event Initiated Date
    2017-03-08
  • 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=154129
  • 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
    System, test, immunological, antigen, tumor - Product Code MOI
  • Reason
    Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) a assay on the advia centaur systems.
  • Action
    Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur¿ Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur¿ Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .

Device

Device Recall Assay for CA 27.29
  • Model / Serial
    All lot codes
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
  • Product Description
    Siemens ADVIA Centaur BR assay || Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) || BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
  • 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