BEUDAMED
    FDA Recall Terminated

    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

    Recall: Z-0072-2020 · Initiated August 19, 2019

    Recall

    Recall Number
    Z-0072-2020
    Event Number
    83603
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 19, 2019
    Terminated
    April 12, 2024
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

    Reason

    Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

    Action

    On 08/19/19, the recalling firm started calling and distributing Urgent Medical Device Recall notices to customers. Laboratory managers were asked to do the following: 1) Run the Abort Count Quantification Protocol. 2) Record the percentage of aborted events on the attached Customer Response Form and submit via fax, email, or online to the recalling firm regardless of the result. 3) For percent aborted events less-than 1.0 percent: your instrument is performing as expected and no further action is required once the percent aborted events has been provided to via Customer Response Form. 4) For percent aborted events greater-than-or-equal-to 1.0 percent: suspend all patient testing. A Technical Representative will contact you within 24 hours (Mon-Fri) of receiving the data (response form) to schedule a service visit. 5) Refer to the Frequently Asked Questions document for more information. Recalling firm is investigating the root cause and to identify actions to prevent recurrence. Customers with additional questions are encouraged to call: Customer/Technical Support at 844-918-0554.

    Distribution

    U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

    Quantity

    30