Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay recall
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Why was Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay recalled?
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
- Product
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Recalling firm
- Hologic, Inc.
- Quantity
- 3
- Distribution
- US: AK
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)