Hologic Recalls Panther Fusion Tube Trays Due to Potential Leaks
Hologic is recalling 607 Panther Fusion Tube Trays because they may leak, potentially invalidating patient results or causing false negatives in flu and RSV assays.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (false negative results and delayed diagnoses) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Hologic, Inc. is recalling 607 units of the Panther Fusion Tube Tray (Part: FAB-15004, REF: PRD-04000). The recall was initiated because the tube trays may leak. This defect could invalidate patient results or assay worklists, leading to delayed results for any assays using the trays.
The source text notes a specific possibility of false negative results with the flu A/B/RSV assay or paraflu assay. The affected units were distributed in the United States and several countries outside the U.S., including Canada, Sweden, the United Kingdom, Germany, and others. Specific lot numbers for the boxes and trays are listed in the recall documentation.
Healthcare facilities and consumers who have these specific tube trays should stop using them and contact Hologic, Inc. for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- Manufacturer
- Hologic, Inc
- Affected units
- 607
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 (7)
- Box/ Tray lots: 271436/ 618539
- 271438/ 620899
- 272089/ 620899
- 272959/ 621837
- 272970/ 621256
- 272971/ 621837
- 274670/ 625351
Distribution
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