Z-2067-2026 Class II Ongoing
FDA device recall Z-2067-2026 was initiated by BioFire Diagnostics, LLC on April 22, 2026 and is designated Class II. Reason for recall: Contamination to in-vitro diagnostic test may result in false positives. The recall status is ongoing. Affected quantity: 106 kits (3,180 test).
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2026
- Initiation Date
- April 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 kits (3,180 test)
Product Description
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Reason for Recall
Contamination to in-vitro diagnostic test may result in false positives.
Distribution Pattern
Worldwide - 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.
Code Information
Lot #s:0883425,0878825/DI: 00815381020192