Panther Fusion Tube Tray — Class II medical device recall Z-1369-2021
Ongoing recall by Hologic, Inc, reported 2021-04-14, distributed nationwide. There is a potential for tube trays to leak which could potentially result in false positive results, false ne
| Recall number | Z-1369-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-04-07 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, ES, FR, GB, HK, IT, NL, NZ |
| Quantity | 1,355 kits |
| Reason classes | packaging |
| Lot numbers | 285762, 285765, 286025, 286026, 286028, 286852, 287410, 289297, 290057, 290068/654833, 290409, 291425, 647288, 648958, 648959, 650655, 650656, 654833, 657545, PRD-0400 |
| Model numbers | FA-15004, FAB-15004, PRD-0400, PRD-04000 |
Product
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Reason for recall
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient 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-1369-2021. 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.