FDA applicant

Quest Diagnostics Nichols Institute

San Juan Capistrano1 decision2025–20250 recalls

FDA records 1 decision for Quest Diagnostics Nichols Institute (San Juan Capistrano) in 2025: 1 original PMA approval. All are in product code QWQ (Assays To Detect Pre-Existing Antibodies To…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Quest Diagnostics Nichols Institute’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Quest Diagnostics Nichols Institute by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Quest”

FDA records each applicant name separately; these may or may not be the same firm.

Quest Medical, Inc. 39 Quest Intl., Inc. 25 Quest Diagnostics, Inc. 8 Quest International, Inc. 3 Quest Dental USA Corp. 2 Quest Medical Imaging 2 Quest Technologies Corp. 1 Quest Enabling Designs, Ltd. 1

Quest Diagnostics Nichols Institute

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Quest”