FDA Device recall Z-1369-2021
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion S…
- FDA Device
- Class II
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion S… by Hologic, citing there is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-26 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hologic |
| Distribution | US |
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
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Identifiers
| code_info | Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288,…Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2021%22
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