The Recall Desk
HighFDA (Devices)·Z-1350-2023·Announced 2023-04-19

First Response Easy Read App unable to reliably read pregnancy test results

Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II medical device with a functional defect that creates a risk of harm through false positive or false negative pregnancy test results, potentially affecting users' medical decisions. No illnesses or injuries have been reported.

Plain-English summary

The Easy Read App associated with First Response Pregnancy Test Sticks is being recalled. The app is designed to convert analog pregnancy test results shown on physical test sticks into text results ('pregnant' or 'not pregnant') displayed on consumer devices such as smartphones or tablets. Approximately 780,000 downloads of the app have been distributed nationwide in the United States.

The app was marketed without obtaining required FDA clearance. Additionally, the app has the potential to fail in critical ways: it may not display any test result on the app screen, or it may misread the analog test results shown on the physical pregnancy test stick. Either failure could cause users to misinterpret their test results, potentially receiving a false positive (indicating pregnancy when not pregnant) or a false negative (failing to detect pregnancy).

This recall affects users of the Easy Read App throughout the United States. If you have used this app to interpret pregnancy test results, do not rely on the app's displayed results. Instead, read the analog test stick results directly according to the manufacturer's instructions. If you have concerns about your test results or pregnancy status, contact your healthcare provider.

The recalled product

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)
Manufacturer
Church & Dwight Inc
Category
Medical Device — Pregnancy Test
Hazard
  • test-misreading
  • false-positive
  • false-negative

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots with the Easy Read App

Distribution

Distributed nationwide across the United States.

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