Skip to content

Siemens ADVIA Centaur Folate recallZ-1564-2014 · Siemens Healthcare Diagnostics, Inc · initiated Mar 25, 2014

Class II Terminated All recalls posted in May 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1564-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 25, 2014
Posted by the FDA
May 7, 2014
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
49123 units
Product code
CGN
FDA submissions
K010050
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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K010050 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page