Events

Recall of Device Recall ADVIA Centaur CA 125II Assay

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
    79678
  • Event Risk Class
    Class 2
  • Event Number
    Z-1486-2018
  • Event Initiated Date
    2018-02-21
  • 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=162958
  • 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
    Test, epithelial ovarian tumor-associated antigen (ca125) - Product Code LTK
  • Reason
    Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
  • Action
    A Customer Notification was sent to customers on 2/21/18. The letter instructs customers to refer to the information provided until the appropriate updates are available in the assay instructions for use. The letter is to be retained and forwarded to those who may have received the product.

Device

Device Recall ADVIA Centaur CA 125II Assay
  • Model / Serial
    SMN 10310443 (1-pack/100 tests): Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427 Lot 73838174, Exp 2018-Apr-27, UDI (01)00630414461298(10)73838174(17)20180427 Lot 88601174, Exp 2018-Apr-27, UDI (01)00630414461298(10)88601174(17)20180427 Lot 94549174, Exp 2018-Apr-27, UDI (01)00630414461298(10)94549174(17)20180427 Lot 23904176, Exp 2018-Aug-30, UDI (01)00630414461298(10)23904176(17)20180830 Lot 24439176, Exp 2018-Aug-30, UDI (01)00630414461298(10)24439176(17)20180830 Lot 31842176, Exp 2018-Aug-30, UDI (01)00630414461298(10)31842176(17)20180830 Lot 42051176, Exp 2018-Aug-30, UDI (01)00630414461298(10)42051176(17)20180830 Lot 54008176, Exp 2018-Aug-30, UDI (01)00630414461298(10)54008176(17)20180830  SMN 10315696 (5-pack/500 tests): Lot 71229174, Exp 2018-Apr-27, UDI (01)00630414461304(10)71229174(17)20180427 Lot 73455174, Exp 2018-Apr-27, UDI (01)00630414461304(10)73455174(17)20180427 Lot 84113174, Exp 2018-Apr-27, UDI (01)00630414461304(10)84113174(17)20180427 Lot 91568174, Exp 2018-Apr-27, UDI (01)00630414461304(10)91568174(17)20180427 Lot 23903176, Exp 2018-Aug-30, UDI (01)00630414461304(10)23903176(17)20180830 Lot 24944176, Exp 2018-Aug-30, UDI (01)00630414461304(10)24944176(17)20180830 Lot 41442176, Exp 2018-Aug-30, UDI (01)00630414461304(10)41442176(17)20180830 Lot 46735176, Exp 2018-Aug-30, UDI (01)00630414461304(10)46735176(17)20180830
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, and Vietnam.
  • Product Description
    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
  • 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