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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare ADVIA Centaur Folate

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 Class 2 Recall
Siemens Healthcare ADVIA Centaur Folate
see related information
Date Posted May 07, 2014
Recall Status1 Open
Recall Number Z-1564-2014
Recall Event ID 67839
Premarket Notification
510(K) Number
K010050 
Product Classification Acid, Folic, Radioimmunoassay - Product Code CGN
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
Code Information 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
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole, Massachusetts 02032-1516
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGN and Original Applicant = BAYER DIAGNOSTICS CORP.
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