BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0930-2014 · Initiated December 18, 2013

    Recall

    Recall Number
    Z-0930-2014
    Event Number
    67021
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    DIP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 18, 2013
    Posted
    February 4, 2014
    Terminated
    May 18, 2016
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    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

    Reason

    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.

    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.

    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.

    Quantity

    1294 (144 units US)