FDA applicant

Alere, Inc.

Scarborough1 decision1984–19840 recalls

FDA records 1 decision for Alere, Inc. (Scarborough) in 1984: 1 original PMA approval. All are in product code LOK (Kit, Test, Alpha-Fetoprotein For Neural Tube…). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Alere, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alere, 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 “Alere”

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

Alere Scarborough, Inc. 17 Alere Scarborough, Inc D/B/A Binax, Inc. 4 Alere Technologies AS 3 Alere San Diego, Inc. 2 Alere, San Diego, Dba Biosite INcorporated, Dba IN 1 Alere San Diego, Inc (Formally Biosite Incorporate 1 Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen 1

Alere, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Alere”