Recall Z-0694-2025— Hologic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc., initiated 2024-11-08. It names one FDA 510(k) clearance: K222736. Product: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400. Reason: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-08
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Reason for recall
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.