Easy Read App associated with First Response Pregnancy Test Sticks — Class II medical device recall Z-1350-2023
Ongoing recall by Church & Dwight Inc, reported 2023-04-19, distributed nationwide. Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is
| Recall number | Z-1350-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Church & Dwight Inc, Princeton, NJ, United States |
| Recall initiated | 2023-01-25 |
| Classified | 2023-04-07 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 780,000 downloads |
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1350-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.