Panther — Class II medical device recall Z-0027-2018
Terminated recall by Hologic, Inc, reported 2017-10-25, distributed in IN. An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R
| Recall number | Z-0027-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-10-18 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2020-07-30 |
| Distributed | IN |
| Quantity | 1 units |
| Reason classes | potency |
| Serial numbers | 20900001124 |
| Model numbers | 902615 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0027-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.