BEUDAMED
    FDA Recall Terminated

    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)

    Recall: Z-2588-2018 · Initiated March 1, 2018

    Recall

    Recall Number
    Z-2588-2018
    Event Number
    80087
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 1, 2018
    Terminated
    December 9, 2025
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)

    Reason

    Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.

    Action

    bioMerieux notified customers on about 03/01/2018, via letter. Instructions included to distribute the recall information to all appropriate personnel in the laboratory, forward the information to individuals to which the product many have been transferred to, destroy any impacted lots on site, and complete and return the Acknowledgement Form. Questions and concerns can be directed to local bioMerieux Customer Service representatives or for Clinical Technical Support Center by email at [email protected].

    Distribution

    Worldwide Distribution - US Nationwide in the state of Arizona and North Carolina. Distributed internationally to Algeria, Algeria, Angola, Argentina, Bahrain, Bangladesh, Belarus, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Colombia, Congo, Costa Rica, Cote d'Ivoire, Czech Republic, Djibouti, Dutch Antilles, Ecuador, Egypt, Estonia, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Mali, Mauretania, Mexico, Morocco, Mozambique, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, Republic of Congo, Romania, Russia, Saudi Arabia, Senegal, Serbia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, Uruguay, United Arab Emirates.

    Quantity

    5,429 units