BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1564-2014 · Initiated March 25, 2014

    Recall

    Recall Number
    Z-1564-2014
    Event Number
    67839
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 25, 2014
    Posted
    May 7, 2014
    Terminated
    April 30, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    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

    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.

    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.

    Quantity

    49123 units