FDAJanuary 25, 2023device
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)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
church dwightchurchchurch dwight
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-252025-10-01
- FDAZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 52025-06-06
- FDAOrajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.2025-06-06
- FDAZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 62025-06-06
- FDATheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 086282023-09-08
- FDAParsley bunches Boxes of 30 and 60 count Keep refrigerated SKU 475987 PLU 4899 on twist ties Product of Mexico2022-12-23
- FDATrue Leaf VA - Romaine Chopped, 6x2 lb. True Leaf Product of USA2021-10-27
- FDAvitafusion Fiber Well 220ct, 10 / 220 CT2021-04-19
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