FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: 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 number
- Z-1564-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2014-03-25
- Posted
- 2014-05-07
- Terminated
- 2015-04-30
- 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
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 49123 units
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K010050"]
- PMA numbers
- not on file
- Product code
- CGN
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28