Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No.

FDA device recall Z-1564-2014 · posted 2014-05-07 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

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 taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CGN

Quantity affected

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 Guadeloup

Date initiated

2014-03-25

Date posted

2014-05-07

Date terminated

2015-04-30

Location

East Walpole, MA

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