Device product
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0027-2018
Product summary
- Firm
- Hologic, Inc
- Event
- Event 78216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0027-2018
Official wording
Reason: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Code information: Serial Number 20900001124
Distribution pattern: Indiana
Derived failure modes
-
Unknown
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.