FDA DevicesClass II
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Published: May 13, 2026Recall ID: Z-2067-2026Category: devicesCountry: US
Reason for Recall / Hazard
Contamination to in-vitro diagnostic test may result in false positives.
Product Description & Identification
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Affected Products
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Additional Source Details
| Field | Value |
|---|---|
| City | Salt Lake City |
| State | UT |
| Event id | 98776 |
| Address 1 | 515 S Colorow Dr |
| Code info | Lot #s:0883425,0878825/DI: 00815381020192 |
| Postal code | 84108-1248 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 106 kits (3,180 test) |
| Reason for recall | Contamination to in-vitro diagnostic test may result in false positives. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260422 |
| Initial firm notification | |
| Center classification date | 20260506 |
Overview
- Recalling FirmBioFire Diagnostics, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.