Events

Recall of Device Recall ADVIA Centaur Folate

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
    65806
  • Event Risk Class
    Class 2
  • Event Number
    Z-2171-2013
  • Event Initiated Date
    2013-07-25
  • Event Date Posted
    2013-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120815
  • 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
    Acid, folic, radioimmunoassay - Product Code CGN
  • Reason
    Calibration failures and/or significant negative shifts in quality control (qc) and patient results.
  • Action
    Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If customers have an alternate lot of the ADVIA Centaur or ADVIA Centaur CP Folate assay, they are instructed that this lot should be used for future testing. However if no alternative lot is available, quality control (QC) results should be obtained for each individual ReadyPack as a QC or calibration is an indication of an affected pack. An affected pack must be replaced with a different Folate ReadyPack where a valid calibration and acceptable QC values are obtained. These notices should be reviewed by the facility's laboratory or medical director, though no look back is required. Customers were instructed that Fedex Return Receipts will be used to confirm that the customers received the UMDC. Customers with questions were instructed to contact their local Technical Support Provider or Distributor. For questions regarding this recall call 508-668-5000.

Device

Device Recall ADVIA Centaur Folate
  • Model / Serial
    22298218
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • Product Description
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • 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