BEUDAMED
    FDA Enforcement Class II Ongoing

    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    Recall: Z-2043-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2043-2023
    Event ID
    92369
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    May 17, 2023
    Classification Date
    June 29, 2023
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    Reason

    Reagent lot numbers include an insufficient concentration of blocking reagent.

    Code Info

    Lot #234320, exp. 7/31/2023, UDI (01)15099590211325(17)230731(11)220731(10)234320; Lot #234134, exp. 6/30/2023, UDI (01)15099590211325(17)230630(11)220630(10)234134; and Lot #234133, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133.

    Distribution

    Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.

    Quantity

    987 kits