Recall Z-1350-2023 — 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)
U.S. FDA — Device Enforcement · United States · 2023-01-25 · Class II
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Reported risk: 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.
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