Recall Z-1350-2023 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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)
| Date | Apr 7, 2023 (initiated Jan 25, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) Church & Dwight Co., Inc., Jun 8, 2009 |