Summary
The FDA issued a Class II for Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 by Hologic, Inc.. Reason: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results..
Details
Source
Device Recall
External ID
Z-0694-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Lot/Code Info: UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Quantity Affected: 3
Reason for Recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Distribution
US: AK
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-08
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hologic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hologic, Inc. have FDA actions?
Hologic, Inc. has 41 FDA actions in our database, including 22 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0694-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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