FDA Actions Against BioFire Diagnostics, LLC

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. BioFire Diagnostics, LLC has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-05-13, Argus HQ recorded a FDA recall for BioFire Diagnostics, LLC, rated "high" severity in Argus HQ's classification: BioFire Diagnostics, LLC — Class II recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for BioFire Diagnostics, LLC, rated "high" severity in Argus HQ's classification: BioFire Diagnostics, LLC — Class II recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, BioFire Diagnostics, LLC has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Frequently asked questions

What is the most recent FDA action against BioFire Diagnostics, LLC?

The most recent FDA event Argus HQ has on file for BioFire Diagnostics, LLC is dated 2026-05-13, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for BioFire Diagnostics, LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to BioFire Diagnostics, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for BioFire Diagnostics, LLC?

3 total: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for BioFire Diagnostics, LLC?

August 19, 2026. Argus HQ ingests new FDA enforcement records daily.

Related enforcement actions

• BioFire Diagnostics, LLC — Class II recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PC… →
• BioFire Diagnostics, LLC — Class II recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 →
• BioFire Diagnostics, LLC — Class II recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. →

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