Panther Fusion Extraction Reagent-X — Class II medical device recall Z-0750-2022
Ongoing recall by Hologic, Inc, reported 2022-03-23, distributed nationwide. Failed stability specifications for reagent kits that may result in false negative test results.
| Recall number | Z-0750-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2022-01-27 |
| Classified | 2022-03-11 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, DE, IT, NL, SE |
| Quantity | 264 kits |
| Reason classes | specification failure |
| Lot numbers | 281330, 281332, 281375, 290312, 290331, 291829 |
| Model numbers | PRD-04477 |
Product
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Reason for recall
Failed stability specifications for reagent kits that may result in false negative test 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-0750-2022. 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.