Recall record at a glance
| Official record | Z-1350-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Church & Dwight Inc. |
| Report date | Apr 19, 2023 |
| Recall initiation date | Jan 25, 2023 |
| Quantity | 780000 downloads |
| Location | Princeton, NJ, United States |
Official product 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)
Why the product was 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.
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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