Recall Z-0694-2025 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
| Date | Dec 20, 2024 (initiated Nov 8, 2024) |
| Status | Open, Classified |
| Reason | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 |
| Quantity | 3 |
| Distribution | US: AK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc., May 16, 2023 |