Recall Z-1350-2023
Church & Dwight Inc · initiated January 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: All lots with the Easy Read App
Reason for recall
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.
FDA-determined cause: No Marketing Application
Action taken
Church & Dwight Company Easy Read App requested the developer to remove the App from the Apple and Google Play app stores on 1/25/23 and third-party vendor disabled the App on consumers devices. Consumers who try to use the downloaded App receive a message that the App is no longer available.
Details
- Recall number
- Z-1350-2023
- Initiated
- January 25, 2023
- Posted by FDA
- April 7, 2023
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Quantity
- 780000 downloads
- Distribution
- US Nationwide distribution.
- Recalling firm
- Church & Dwight Inc, Princeton, NJ