BEUDAMED
    FDA Enforcement Class II Ongoing

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    Recall: Z-1298-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1298-2023
    Event ID
    91723
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Entopsis , Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2023
    Initiation Date
    February 21, 2023
    Classification Date
    March 29, 2023
    Address
    7600 Nw 69th Ave, N/A, Medley, FL, 33166-2521, United States

    Description

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    Reason

    Presence of misleading label statements on the product label.

    Code Info

    a) REF 597000, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 6024; b) REF 597825, Lot Numbers: 5, Exp. 06/2024; c) REF 597850, Lot Numbers: 2, Exp. 05/2024; d) REF 5970025, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 06/2024; 4, Exp. 06/2024; 5, Exp. 06/2024; e) REF 5971000, Lot Numbers: 4, Exp. 06/2024

    Distribution

    Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

    Quantity

    363 units