# FDA recall Z-1350-2023

> **Church & Dwight Inc** · Class II · device recall initiated 2023-01-25.

## 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)

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1350-2023
- **Recalling firm:** Church & Dwight Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-25
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2023

## Citation

> AI Analytics. FDA recall Z-1350-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1350-2023. Source: US FDA. Licensed CC0.

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