BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

    Recall: Z-1186-2012 · Initiated October 3, 2008

    Recall

    Recall Number
    Z-1186-2012
    Event Number
    60321
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 3, 2008
    Posted
    March 7, 2012
    Terminated
    March 8, 2012
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

    Reason

    Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

    Action

    Siemens sent an "URGENT FIELD SAFETY NOTICE" dated October 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructed customer to immediately discontinue the use of ADVIA Centaur Intact PTH (iPTH) assay kits that contain intact PTH (iPTH) reagent lot 138. It also recommended that for serum samples analyzed on the ADVIA Centaur CP system, the content of the Urgent Field Safety Notice be discussed with their laboratory director to determine the need to review previous test results, conduct patient follow up, and repeat testing for iPTH results that were less than the upper limit of the reference range, and had a companion calcium result that was elevated or at the upper limit of normal. Additionally, a Completion Notification form was attached for customers to complete and return. Customers should contact their local technical support provider for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.

    Quantity

    100 Test =5768; 500 Test =1778