Recall Z-2990-2020 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Hologic, Inc
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
| Date | Aug 4, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 607 |
| Distribution | U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.