FDA Device recall Z-0027-2018
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use by Hologic, citing an incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0027-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-15 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | IN |
Product
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Reason
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
Identifiers
| code_info | Serial Number 20900001124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2018%22
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