FDA Medical devices recall ·
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay recall
- Recall number
- Z-0694-2025
- Date
- (initiated November 8, 2024)
- Company / brand
- Hologic, Inc
10210 Genetic Center Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Why was it recalled?
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Distribution
US: AK
States: Alaska
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0694-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.