First Response™ Pregnancy Early Result
Model 00022600001317 · CHURCH & DWIGHT CO., INC. · DI 00022600001317
LCX — Kit, Test, Pregnancy, Hcg, Over The Counter · Class II · 21 CFR 862.1155
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-10-04 | Z-0266-2024 | Class II | Open, Classified | Products were stored outside of labeled temperature requirements. | k number procode |
| 2022-06-23 | Z-1537-2022 | Class II | Open, Classified | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2024-10 | 0 | 2 |
| 2025-07 | 0 | 2 |
Regulatory clearances
- K123436 SESE 2013-08-26 (k number procode)
Predicate lineage
K123436 — cited as predicate by K150022, K172257, K212418
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CHURCH & DWIGHT CO., INC.
- Warning Letter 2011-05-16 Church & Dwight Inc
- Warning Letter 2011-05-16 Church & Dwight Inc
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