Panther Fusion CE-IVD Labeling Checklist

Verify the 2 new labels list the same manufacturing dates. If the dates do NOT match, stop and contact Technical Support. Remove the existing label from the chassis inside the module and replace it with the new CE-IVD label. (This label lists the module Serial Number.) Remove the existing faceplate from the module and replace it with the new faceplate that has the new CE-IVD label without Serial Number. Take a closeup photo of the 2 CE-IVD labels including the UDI tracking label. All information on each label must be clear and legible. All necessary service activities required to upgrade this system to CE-IVD configuration are complete.

Panther Serial Number:
Fusion Serial Number:
Date:
FSE Name (Print):
FSE Signature:

Return this Checklist (scan or email) with the photos of the labels to:

Zac Bullock (Quality and Inspection Department, Hologic, Inc., San Diego, CA
Email: zac.bullock@hologic.com

OR

Felipe Balagtas (Quality and Inspection Department, Hologic, Inc., San Diego, CA
Email: felipe.balagtas@hologic.com