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Lower risk Medical device recall · FDA · Published January 25, 2023

First Response Pregnancy Test Sticks: Easy Read App May Show Incorrect Results

Church & Dwight recalls First Response Pregnancy Test Sticks with Easy Read App due to potential misreading of test results, leading to false positives or negatives. Consumers should check if their test sticks have the app.

🇺🇸 FDA recall #Z-1350-2023Medical deviceChurch & Dwight ›
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Recalling firmChurch & Dwight Inc469 N Harrison St · Princeton, NJ 08540-3510
✎ GovInfoNow plain-language explainer

Church & Dwight is recalling First Response Pregnancy Test Sticks that use the Easy Read App to convert analog results into text. The app may not read test results correctly, causing false positives or negatives that could lead to incorrect pregnancy conclusions. Read more at govinfonow.com/recall/59005-first-response-pregnancy-test-sticks-easy-read-app-may-show.

Source Summary by GovInfoNow · govinfonow.com/recall/59005-first-response-pregnancy-test-sticks-easy-read-app-may-show · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1350-2023

Cite this page

“First Response Pregnancy Test Sticks: Easy Read App May Show Incorrect Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59005-first-response-pregnancy-test-sticks-easy-read-app-may-show. Based on FDA recall #Z-1350-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1350-2023%22&limit=1).

The FDA announced on Jan. 25, 2023, that Church & Dwight Inc is recalling the Easy Read App associated with First Response Pregnancy Test Sticks because it was marketed without a required new 510k. The app may fail to read test results or misread analog lines, potentially leading users to interpret false positive or negative outcomes.

How to tell if you have it

  • Brand: Church & Dwight
  • Product: Easy Read App associated with First Response Pregnancy Test Sticks
  • Quantity: 780,000 downloads

The hazard

Church & Dwight stated that the Easy Read App may be unable to read test results or misread analog results shown on the pregnancy test stick. This error could lead to the misinterpretation of false positive or false negative tests by the user.

Context

GovInfoNow's records show Church & Dwight Inc has five other recalls on record since Sept. 6, 2012. Other recent recalls include ZICAM Cold Remedy Nasal Swabs (June 6, 2025), TheraBreath for Kids (Sept. 8, 2023), and Church & Dwight Gummy Vites L'il Critters Multivitamin (June 4, 2015). Other recent recalls of similar products include hCG Pregnancy Tests May Give False Positives - Alere Recall (Aug. 20, 2026) and LH One Step Ovulation Test Device Recall (Nov. 22, 2025).

How to tell if you have this one

Check if your First Response Pregnancy Test Sticks include the Easy Read App for converting analog results into text. The app is part of the test sticks sold with the intended use of displaying results on phones or tablets.

  • Brand
    Church & Dwight
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check App Functionality

    Ensure the Easy Read App displays results correctly on your device. If it shows no results or misreads the test, stop using it.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jan 25, 202312. FDA classified it Class II: Apr 7, 202323. Published in FDA’s Enforcement Report: Apr 19, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1350-2023 (January 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1350-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA