Biofire Diagnostics
Medical device establishment · Salt Lake City, UT
Biofire Diagnostics, based in Salt Lake City, UT, has 3 FDA recalls on file.
FDA record
Recent FDA actions
Questions about Biofire Diagnostics
No warning letter naming Biofire Diagnostics is on file. FDA has published 3 recalls naming it.
Yes. FDA's enforcement reports list 3 recalls by Biofire Diagnostics; the latest, reported on 2026-10-21, is a Class II recall.
Biofire Diagnostics is based in Salt Lake City, UT. The address is the one on its FDA records, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Biofire Diagnostics; every record links to the source, and nothing here is advice.
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