Recall Z-2990-2020— Hologic, Inc
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc, initiated 2020-08-04, terminated 2024-12-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000. Reason: Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-04
- Terminated
- 2024-12-23
- Firm location
- San Diego, CA, United States
Product description
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Reason for recall
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.