BEUDAMED
    FDA Recall Terminated

    VIDAS CMV IgM 30 Tests

    Recall: Z-1408-2021 · Initiated March 16, 2021

    Recall

    Recall Number
    Z-1408-2021
    Event Number
    87555
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LKQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 16, 2021
    Terminated
    August 6, 2024
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VIDAS CMV IgM 30 Tests

    Reason

    bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).

    Action

    A Recall notification letter titled, "IMPORTANT: URGENT FIELD SAFETY NOTICE" was sent to the to the impacted subsidiaries and distributors on 03/16/2021 via email. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The recalling firm requested that the consignees conduct the following actions: 1 - Please distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product. 2 - Stop using and destroy any stock of lots VIDAS CMV IgM (Ref. 30205 and 30205-01) lots mentioned in Table 1 remaining in their inventory and not already discarded through the Urgent Field Safety notice related to FSCA#5087 3 - Complete the Acknowledgement Form in Attachment A and return it to their local bioMrieux representative to confirm receipt of this notice. 4 - Contact their local customer service if they have any questions.

    Distribution

    Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Fed., Sweden, Singapore, Thailand, Turkey, South Africa, Algeria, Angola, Bahrain, Belarus, Benin, Bolivia, Bosnia-Herz., Bulgaria, Burkina Faso, Cameroon, Cape Verde, Chad, Costa Rica, Croatia, Dem. Rep. Congo, Dominican Rep., Dutch Antilles, Ecuador, El Salvador, Georgia, Guatemala, Indonesia, Iran, Iraq, Israel, Kenya, Lebanon, Lithuania, Macedonia, Mali, Malta, Mongolia, Morocco, Mozambique, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sril Lanka, Syria, Tunisia, Uruguay, Utd.Arab Emir., Vietnam, Djibouti, Equatorial Guin, Zambia, Cap Verde

    Quantity

    18705 kits