FDA Device recall Z-2067-2026
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit by Biofire Diagnostics, citing contamination to in-vitro diagnostic test may result in false positives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2067-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-22 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Reason
Contamination to in-vitro diagnostic test may result in false positives.
Identifiers
| code_info | Lot #s:0883425,0878825/DI: 00815381020192 |
|---|
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-2067-2026%22
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