Reported Apr 19, 2023 · Ongoing
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test…
Church & Dwight Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Church & Dwight Inc · 469 N Harrison St · Princeton, NJ · 08540-3510
Is this the product you have?
- 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)
- Lot codes and dates
- All lots with the Easy Read App
- Amount recalled
- 780000 downloads
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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