Medical device recalls Moderate risk

Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Recall date
November 8, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0694-2025
FDA classification
Class II
Brand / firm
Hologic, Inc.
Sold / distributed
US: AK

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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