Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reported: January 1, 2025 Initiated: November 8, 2024 #Z-0694-2025
Product Description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reason for Recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Details
- Recalling Firm
- Hologic, Inc.
- Units Affected
- 3
- Distribution
- US: AK
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400. Recalled by Hologic, Inc.. Units affected: 3.
Why was this product recalled? ▼
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0694-2025.
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