Z-1350-2023 Class II Ongoing
FDA device recall Z-1350-2023 was initiated by Church & Dwight Inc on January 25, 2023 and is designated Class II. 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 resu… The recall status is ongoing. Affected quantity: 780000 downloads.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- January 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 780000 downloads
Product 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 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.
Distribution Pattern
US Nationwide distribution.
Code Information
All lots with the Easy Read App