CLASS II ONGOING Device recall · Reported 19 Apr 2023 · FDA Enforcement Report
Easy Read App associated with First Response Pregnancy Test Sticks recalled
Church & Dwight is recalling Easy Read App associated with First Response Pregnancy Test Sticks, distributed nationwide in the US. The recall was initiated on 25 Jan 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1350-2023
- FDA event ID
- 91758
- Recalling firm
- Church & Dwight, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jan 2023
- FDA classified
- 7 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jan 2023 | Recall initiated by company | |
| 7 Apr 2023 | Classified by FDA | +72 days |
| 19 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots with the Easy Read App
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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