FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Recall number
- Z-0694-2025
- Recalling firm
- Hologic, Inc.
- Product
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Status
- Open, Classified
- Initiated
- 2024-11-08
- Posted
- 2024-12-20
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
- 510(k) numbers
- ["K222736"]
- PMA numbers
- not on file
- Product code
- QOF
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28