Class II

Medical Device Recall: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Hologic, Inc. · November 8, 2024

Reason for Recall

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

Distribution

US: AK

States Affected

AK

Quantity Affected

3

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0694-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hologic, Inc. Medical Device Recall: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | SafeCheck