FDA applicant

Quest Intl., Inc.

North Miami, FL25 decisions1989–20094 recalls

FDA records 25 decisions for Quest Intl., Inc. (North Miami, FL) from 1989 to 2009: 25 510(k) clearances. Most are in product codes LSE (Epstein-Barr Virus, Other) and LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). 4 recalls are linked to its devices.

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

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

How often FDA has decided Quest Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Quest Intl., Inc. by year, 2007–2026Sources: 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 Diagnostics, Inc. 8 Quest International, Inc. 3 Quest Dental USA Corp. 2 Quest Medical Imaging 2 Quest Diagnostics Nichols Institute 1 Quest Technologies Corp. 1 Quest Enabling Designs, Ltd. 1

Quest Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Quest”