FDA Device recall Z-0602-2026
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) by Biofire Diagnostics, citing due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0602-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-22 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | AZ, FL, GA, ID, NC, NH, NJ, NY, OR, PA, SC |
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Reason
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Identifiers
| code_info | UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2026%22
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