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

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.

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.