BEUDAMED
    FDA Recall Terminated

    Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

    Recall: Z-2576-2021 · Initiated August 4, 2021

    Recall

    Recall Number
    Z-2576-2021
    Event Number
    88565
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    OVQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 4, 2021
    Terminated
    May 31, 2023
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

    Reason

    Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

    Action

    On about 08/04/2021, Abbott Molecular notified consignees via FedEx with letter titled "Urgent Field Safety Notice Molecular Diagnostics at Abbott Product: Vysis CLL FISH Probe." The letter instructed customers to discontinue use of the affected lots, discard any remaining kits on hand, complete and return the customer reply form, and notify impacted customers if the affected lots have been further distributed. Additional instructions included to review the recall notification information with your Medical Director or physicians as appropriate and retain the communication for future reference. Review patient results generated with the impacted lots and determine if retesting is required taking patient medical history and previous treatment into consideration.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MI, MN, MA, NC, NJ, NM, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and the countries of Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Estonia, Germany, Hong Kong, Israel, Italy, Kazakhstan, Netherlands, Philippines, Poland, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, United Kingdom, Uruguay.

    Quantity

    186 units