Events

Recall of Device Recall Siemens Healthcare 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
    67839
  • Event Risk Class
    Class 2
  • Event Number
    Z-1564-2014
  • Event Initiated Date
    2014-03-25
  • Event Date Posted
    2014-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126468
  • 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
    Serum controls may go out of range low with the advia centaur ¿systems folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223.
  • Action
    Siemens issued An Urgent Medical Device Recall (UMDR) to US customers on March 25, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on March 24, 2014. These notices inform the customer of reported controls failures with Folate ReadyPack¿ kit lots ending in 223. In addition the notices inform customers of a shift when moving from Folate ReadyPack¿ kit lots ending in 219 and kit lots ending in 222, 224, 225, 226 and 227. Customers were instructed to discontinue use of ADVIA Centaur¿ Systems Folate kit lots ending in 219 and 223. ADVIA Centaur¿ systems Folate kit lots ending in 222, 224, 25, 226 and 227 are performing within specification and may continue to be used for folate interpretation. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm customers received the notification.

Device

Device Recall Siemens Healthcare ADVIA Centaur Folate
  • Model / Serial
    Kit Lots ending in and exp date: 219 Exp. Date 25 March, 2014; 222 Exp Date 12 May, 2014; 224 Exp Date 04 August, 2014; 225 Exp Date 04 August, 2014; 226 Exp Date 12 September, 2014; 227 Exp. Date 06 October, 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir.
  • Product Description
    Siemens ADVIA Centaur Folate || Cat No. 06891541 SMN 10325366 (500 tests) || Cat No. 06367974 SMN 10310308 (100 tests) || Cat No. 00203473 SMN 10331250 (Ref) (500 tests) || Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) || For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells 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