BEUDAMED
    FDA Enforcement Class II Ongoing

    PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

    Recall: Z-1300-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1300-2023
    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 Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

    Reason

    Presence of misleading label statements on the product label.

    Code Info

    a) REF 78378001, Lot Numbers: 4, Exp. 02/2023; 7, Exp. 07/2023; b) REF 78378025, Lot Numbers: 6, Exp. 06/2023; c) REF 78378100, Lot Numbers: 7, Exp. 07/2023

    Distribution

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

    Quantity

    97 units