PANTHER FUSION System REF 9121010000 The Panther System is an… — Class II medical device recall Z-0782-2024
Ongoing recall by Hologic, Inc., reported 2024-01-31, distributed nationwide. Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
| Recall number | Z-0782-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., San Diego, CA, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-01-23 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, DE, DK, DO, ES, FR, GB, HK, IE, IT, KR, KW, NL, NO, NZ, PT, QA, SE |
| Model numbers | 9121010000, ASY-09600 |
Product
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.
Reason for recall
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
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-0782-2024. 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.