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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack

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  Class 2 Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack see related information
Date Initiated by Firm December 18, 2013
Date Posted February 04, 2014
Recall Status1 Terminated 3 on May 18, 2016
Recall Number Z-0930-2014
Recall Event ID 67021
510(K)Number K011393  
Product Classification Enzyme immunoassay, diphenylhydantoin - Product Code DIP
Product ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack
SMN 10314977

For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Code Information Lot # Expiry Date  18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer Reason
for Recall		 ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthcare Diagnostics Customer Notification notice was sent to affected Siemens Healthcare Diagnostic customers in the United States on December 18, 2013.. The notifications inform customers that Siemens Healthcare Diagnostics received customer feedback regarding the performance of the ADVIA Centara¿ Systems Phenytoin assay, indicating that the assay was recovering higher relative to the performance of other assays in proficiency studies. Siemens internal investigation confirmed the positive bias for Calibrator N lot CN 57 in the ADVIA Centaur Systems Phenytoin assay. This lot has expired and is no longer in use. Expected performance has been restored starting with Calibrator N lot CN58. Siemens is notifying customers that have received Calibrator N lots CN58 and higher that there will be a change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens is providing data to inform customers of the expected difference between Calibrator lots CN58 and higher versus prior Calibrator N lots. Customers were instructed to retain the letter with their laboratory records, and forward to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customers Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.
Quantity in Commerce 1294 (144 units US)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DIP and Original Applicant = RANDOX LABORATORIES, LTD.
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