Recall Z-1369-2021— Hologic, Inc
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc, initiated 2021-02-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-02-26
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.