Recall Z-0027-2018 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Hologic, Inc
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
| Date | Sep 15, 2017 |
| Status | Terminated |
| Reason | An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. |
| Root cause | Employee error |
| Action | The customer was notifed of the potential incorrect results via a phone call on September 15, 2017. A customer letter was sent on September 18, 2017. The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017 Aug 30, 2017. |
| Quantity | 1 unit |
| Distribution | Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) Hologic / Gen-Probe Incorporated, Oct 17, 2013 |