Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test re
FDA device recall Z-1350-2023 · posted 2023-04-07 · Open, Classified
Recall details
- Recalling firm
- Church & Dwight Inc
- 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.
- 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.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- LCX
- Quantity affected
- 780000 downloads
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-01-25
- Date posted
- 2023-04-07
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) (K083716) | Church & Dwight Co., Inc. | 2009-06-08 |