BEUDAMED
    FDA Enforcement Class II Terminated

    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

    Recall: Z-1752-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1752-2020
    Event ID
    85289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 29, 2020
    Initiation Date
    September 4, 2019
    Classification Date
    April 20, 2020
    Termination Date
    April 28, 2021
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

    Reason

    Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

    Code Info

    Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175. .

    Distribution

    Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.

    Quantity

    7,951 units