FDA Device recall Z-2990-2020
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 by Hologic, citing 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 negat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2990-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-04 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hologic |
| Distribution | AL, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, MA, ME, NC, NJ, NY, OK, OR, SC, TN, TX, UT, VA, VT, WA, WI |
Product
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Reason
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.
Identifiers
| code_info | Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2990-2020%22
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