Z-0027-2018 Class II Terminated
FDA device recall Z-0027-2018 was initiated by Hologic, Inc on September 15, 2017 and is designated Class II. Reason for recall: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. The recall status is terminated (terminated July 30, 2020). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- July 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Reason for Recall
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Distribution Pattern
Indiana
Code Information
Serial Number 20900001124