Hologic Recalls Panther Fusion Tube Trays Due to Potential Leakage
Hologic is recalling 1,355 Panther Fusion Tube Trays because they may leak, potentially causing false positive, false negative, or invalid patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device where a defect (leakage) poses a risk of harm by producing invalid or incorrect patient results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Hologic, Inc. is recalling 1,355 units of the Panther Fusion Tube Tray (REF PRD-04000, PN: FA-15004). This product is an ancillary consumable used with the Panther Fusion System to contain the PCR and RT-PCR steps of assay processing.
The recall was initiated because there is a potential for the tube trays to leak. This leakage could potentially result in false positive results, false negative results, or invalid patient results.
The affected products were distributed worldwide, including nationwide in the United States and in various countries in Europe, Asia, and Oceania. Specific lot numbers are listed in the agency's recall record. Users of the Panther Fusion System should check their inventory for the affected part and catalog numbers and contact Hologic for instructions on how to proceed.
The recalled product
- Product
- Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
- Manufacturer
- Hologic, Inc
- Hazard
- Affected units
- 1,355
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 (11)
- 285765 / 647288
- 286025 / 648958
- 286026 / 648958
- 286028 / 648959
- 286852 / 650655
- 287410 / 650656
- 289297 / 648959
- 290057 / 647288
- 290068/654833
- 290409 / 654833
- 291425 / 657545
Distribution
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