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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