Panther Fusion recallZ-0694-2025 · Hologic, Inc. · initiated Nov 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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 [email protected] If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or [email protected]
Recall details
- Recall number
- Z-0694-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 8, 2024
- Posted by the FDA
- Dec 20, 2024
- Recalling firm
- Hologic, Inc.
- Quantity
- 3
- Product code
- QOF
- FDA submissions
- K222736
- Distribution
- US: AK
Product description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Code information (models, lots, serial numbers)
UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Panther Fusion® KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVDHologic, Inc. · Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents1 recall7 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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