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Submission: On April 08 via manual (April 8th 2023, 8:22:30 am UTC) from US — Scanned from DE

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1 forms found in the DOM

GET https://www.fda.gov/search

<form id="search_form" action="https://www.fda.gov/search" accept-charset="UTF-8" method="get">
  <label class="searchlable" for="query">Search FDA</label>
  <input accesskey="4" type="text" name="s" id="query" autocomplete="off" class="usagov-search-autocomplete">
  <div id="go_button" style="left:150px">
    <a href="javascript:document.getElementById('search_form').submit();" title="Search this site"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"></a>
  </div>
</form>

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CLASS 2 DEVICE RECALL EASY READ APP

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Class 2 Device Recall Easy Read App 22

Date Initiated by Firm January 25, 2023 Date Posted April 07, 2023 Recall
Status1 Open3, Classified Recall Number Z-1350-2023 Recall Event ID 9175823
510(K)Number K08371624 Product Classification Kit, test, pregnancy, hcg, over
the counter25 - Product Code LCX26
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
609-279-7748 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 Report27

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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 recalls28.
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.29

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1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www.addthis.com/bookmark.php
3. https://www.fda.gov/
4. http://www.fda.gov/MedicalDevices/default.htm
5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
6. /scripts/cdrh/devicesatfda/index.cfm
7. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm
8. /scripts/cdrh/cfdocs/cfpmn/denovo.cfm
9. /scripts/cdrh/cfdocs/cfRL/rl.cfm
10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
11. /scripts/cdrh/cfdocs/cfRES/res.cfm
12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm
13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm
14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm
15. /scripts/cdrh/cfdocs/cfStandards/search.cfm
16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
20. /scripts/cdrh/cfdocs/cfClia/Search.cfm
21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
22. http://www.fda.gov/safety/recalls/enforcementreports/default.htm
23. /scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=91758
24. /scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083716
25. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=LCX
26. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=LCX
27. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=LCX
28. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm
29. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm?start_search=1&productcode=LCX&knumber=&applicant=CHURCH%20%26%20DWIGHT%20CO%2E%2C%20INC%2E

Page Last Updated: 04/07/2023

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www.accessdata.fda.gov Open in urlscan Pro 2a02:26f0:6c00:1b6::308a Public Scan

Form analysis 1 forms found in the DOM

GET https://www.fda.gov/search

Text Content

www.accessdata.fda.gov Open in urlscan Pro
2a02:26f0:6c00:1b6::308a Public Scan

Form analysis
1 forms found in the DOM