BEUDAMED
    FDA Enforcement Class II Terminated

    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

    Recall: Z-2391-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2391-2018
    Event ID
    80110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ekla Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 18, 2018
    Initiation Date
    October 20, 2016
    Classification Date
    July 9, 2018
    Termination Date
    November 29, 2023
    Address
    1707 Quincy Ave Ste 127, Naperville, IL, 60540-6692, United States

    Description

    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

    Reason

    Incorrect hCG results

    Code Info

    Lot # F606032 (exp 2018-05)

    Distribution

    US National Distribution in the states of CA, IL, MN and RI

    Quantity

    295 kits