CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Panther Fusion Sars-CoV-2/Flu A/B/RSV Assay recalled by Hologic
Hologic is recalling Panther Fusion Sars-CoV-2/Flu A/B/RSV Assay, distributed in Alaska. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0694-2025
- FDA event ID
- 95731
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +42 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Where it was distributed
US: AK
Questions about this recall
Why was it recalled?
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Which lots are affected?
UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Where was it sold?
US: AK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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