BEUDAMED
    FDA Enforcement Class II Ongoing

    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

    Recall: Z-1350-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1350-2023
    Event ID
    91758
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Church & Dwight Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 19, 2023
    Initiation Date
    January 25, 2023
    Classification Date
    April 7, 2023
    Address
    469 N Harrison St, N/A, Princeton, NJ, 08540-3510, United States

    Description

    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

    Reason

    Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.

    Code Info

    All lots with the Easy Read App

    Distribution

    US Nationwide distribution.

    Quantity

    780000 downloads