FDA Medical Device Recalls (openFDA)
Church & Dwight Inc: 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 number
- Z-1350-2023
- Recalling firm
- Church & Dwight Inc
- 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)
- Status
- Open, Classified
- Initiated
- 2023-01-25
- Posted
- 2023-04-07
- Terminated
- not on file
- 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.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- 780000 downloads
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All lots with the Easy Read App
- 510(k) numbers
- ["K083716"]
- PMA numbers
- not on file
- Product code
- LCX
- Firm FEI
- 2280705
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28