BioFire Joint Infection (JI) Panel recallZ-2067-2026 · BioFire Diagnostics, LLC · initiated Apr 22, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Contamination to in-vitro diagnostic test may result in false positives.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 22, 2026, bioMerieux issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. bioMerieux asked consignees to take the following actions: 1 Examine your inventory for the lots identified in this recall notification. 2 Discontinue use and discard any remaining product from this lot in your possession. 3 Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. 4 If the product has been transferred to another facility, please notify the facility and appropriate personnel. 5 If you have further distributed this product, please identify any recipients and notify them at once. 6 Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.
Recall details
- Recall number
- Z-2067-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2026
- Posted by the FDA
- May 6, 2026
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 106 kits (3,180 test)
- Product code
- QSN
- 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.
Product description
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Code information (models, lots, serial numbers)
Lot #s:0883425,0878825/DI: 00815381020192
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioFire® Joint Infection (JI) Panel RFIT-ASY-0138Biofire Diagnostics, LLC · Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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