BEUDAMED
    FDA Recall Open, Classified

    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

    Recall: Z-1299-2023 · Initiated February 21, 2023

    Recall

    Recall Number
    Z-1299-2023
    Event Number
    91723
    Firm
    Entopsis Inc.
    FEI Number
    3016994927
    Product Code
    JJH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 21, 2023
    Posted
    March 29, 2023
    Address
    7600 Nw 69th Ave, Medley, FL, 33166-2521

    Description

    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

    Reason

    Presence of misleading label statements on the product label.

    Action

    The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 02/21/22023 by email. Those without a valid email address were mailed the notice via certified mail. The notice explained the issue and risk and requested the customer/user take the following actions: "Entopsis Inc., requests that the product lots listed below - shipped/received before February 8st, 2023 be promptly discontinued from use and discarded from inventory as per your non-hazardous waste disposal plan.The labeling of PCRopsis products was revised on February 8th, 2022. Updated statements of intended use and revised instructions for use are available on www.pcropsis.com. If you are currently using or intend to use the PCRopsis product lots affected by this recall please contact us at [email protected] or 1-888-407-5070 (Monday to Friday 9.00 AM to 4.30 PM Eastern Time) to request a replacement. If you are a re-distributor of PCRopsis devices, notify your end customer with a copy of this letter. Please acknowledge the removal of affected product lots by filling out the attached acknowledgment form and returning it to us at [email protected]. Contact us at [email protected] or 1-888-407-5070 - Monday to Friday 9.00 AM to 4.30 PM US Eastern Time (GMT -5) with any questions you may have."

    Distribution

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

    Quantity

    397 units