FDA Device

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Hazard

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.

What You Should Do

Remedy

On 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.

Products

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Brand
Hologic, Inc
UPC
Box/ Tray lots: 271436/ 618539,  271438/ 620899,  272089/ 620899,  272959/ 621837,  272970/ 621256,  272971/ 621837,  274670/ 625351

Units Affected

607