Church & Dwight Inc Recall 91758
Description: 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)
Church & Dwight Inc Recall 91758 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1350-2023 |
| Event ID | 91758 |
| Event Description | 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 Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 780000 downloads |
| Recall Reason | 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. |
| Device Classification | 20230419 |
| Device Code Info | All lots with the Easy Read App |
| Center Classification Date | 20230407 |
| Recall Initiation Date | 20230125 |
| Recalling Firm | Church & Dwight Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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