FDA Recall
Open, Classified
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Recall: Z-0694-2025
·
Initiated November 8, 2024
Recall
- Recall Number
- Z-0694-2025
- Event Number
- 95731
- Firm
- Hologic, Inc.
- FEI Number
- 2024800
- Product Code
- QOF
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- November 8, 2024
- Posted
- December 20, 2024
- Address
- 10210 Genetic Center Dr, San Diego, CA, 92121-4362
Description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reason
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
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 [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]
Distribution
US: AK
Quantity
3