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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Read App

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  Class 2 Device Recall Easy Read App see related information
Date Initiated by Firm January 25, 2023
Date Posted April 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-1350-2023
Recall Event ID 91758
510(K)Number K083716  
Product Classification Kit, test, pregnancy, hcg, over the counter - Product Code LCX
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)
Code Information All lots with the Easy Read App
Recalling Firm/
Manufacturer		 Church & Dwight Inc
469 N Harrison St
Princeton NJ 08540-3510
For Additional Information Contact SAME
800-367-6022
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 780000 downloads
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LCX and Original Applicant = CHURCH & DWIGHT CO., INC.
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