Panther Fusion Tube Tray — Class II medical device recall Z-2990-2020
Terminated recall by Hologic, Inc, reported 2020-09-30, distributed in AL, CA, CO, CT, DC, FL, GA, HI…. Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any
| Recall number | Z-2990-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2020-08-04 |
| Classified | 2020-09-21 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2024-12-23 |
| Distributed | AL, CA, CO, CT, DC, FL, GA, HI, ID, IL, MA, ME, NC, NJ, NY, OK, OR, SC, TN, TX, UT, VA, VT, WA, WI |
| Quantity | 607 |
| Reason classes | potency, packaging |
| Lot numbers | 271436, 271438, 272089, 272959, 272970, 272971, 274670, 618539, 620899, 621256, 621837, 625351 |
| Model numbers | FAB-15004, PRD-04000 |
Product
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Reason for recall
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
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-2990-2020. 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.