FDA Device recall Z-2081-2026
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 by Biofire Diagnostics, citing respiratory/sore throat panel test may result in false negative results and control failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2081-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-01 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason
Respiratory/sore throat panel test may result in false negative results and control failures.
Identifiers
| code_info | Lot Number: 2215125/UDI: 00815381020390 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.