Z-1350-2023Class II

Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog...

Name: Z-1350-2023 Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog...
Creator: Church & Dwight Inc
Published: 2023-01-25
License: https://open.fda.gov/license/

Church & Dwight Co., Inc. / initiated 2023-01-25 / Open, Classified

FDA source

Church & Dwight Inc began a recall of Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not... on 2023-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1350-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-25
Posted: 2023-04-07
Recalling firm: Church & Dwight Co., Inc.
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)
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 root cause: 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.
Product codes and lots: All lots with the Easy Read App

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-07

Product code LCX

K083716Class IIFirst Response Early Result Pregnancy Test (OTC)Church & Dwight Co., Inc. / cleared 2009-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)