Panther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall with no reported hospitalizations or illnesses. The hazard—potential false positive diagnostic results—presents a risk of harm without documented injury, meeting the rubric criterion for High (3) severity.
Plain-English summary
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits manufactured by Hologic, Inc., which are used to detect respiratory viruses, are being recalled due to the potential for producing erroneous false positive results for SARS-CoV-2. The FDA has classified this as a Class II recall.
The specific affected lots are Kit lot 892307 (expiration date May 15, 2025) and Cartridge lot 890494, identified by UDI-DI 15420045515352. This recall affects a limited quantity distributed in Alaska.
Healthcare facilities and laboratories using these specific lots should discontinue use. Any positive SARS-CoV-2 results from affected lots should be verified using an alternative testing method before clinical action is taken.
The recalled product
- Product
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Manufacturer
- Hologic, Inc.
- Category
- Medical Device
- Hazard
- false-positive-results
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 15420045515352 Kit lot 892307
- Expiration: May 15
- 2025. Cartridge Lot 890494
Distribution
Distributed in 1 state:
- AK
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