Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
FDA device recall Z-0694-2025 · posted 2024-12-20 · Open, Classified
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- Action taken
- On 11/8/24, recall notices were mailed to customers asking them to do the following: 1) Discontinue use, and discard affected kits. 2) Complete and return the customer response firm via email to molecularsupport@hologic.com If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or molecularsupport@hologic.com
- Root cause
- Unknown/Undetermined by firm
- Status
- Open, Classified
- Product code
- QOF
- Quantity affected
- 3
- Distribution
- US: AK
- Date initiated
- 2024-11-08
- Date posted
- 2024-12-20
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736) | Hologic, Inc. | 2023-05-16 |