Device 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)
Z-1350-2023
Product summary
- Event
- Event 91758
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 780000 downloads
- Official record key
device-enforcement:Z-1350-2023
Official wording
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 information: All lots with the Easy Read App
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.