BioFire Joint Infection recall: Contamination
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Why was BioFire Joint Infection recalled?
Contamination to in-vitro diagnostic test may result in false positives.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s:0883425,0878825/DI: 00815381020192
- Product
- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 106 kits (3,180 test)
- Distribution
- 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.
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)