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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire Joint Infection (JI) Panel

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 Class 2 Device Recall BioFire Joint Infection (JI) Panelsee related information
Date Initiated by FirmApril 22, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2067-2026
Recall Event ID 98776
Product Classification Orthopedic infection microbial multiplex nucleic acid detection system - Product Code QSN
ProductBioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Code Information Lot #s:0883425,0878825/DI: 00815381020192
FEI Number 3002773840
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information ContactCustomer Support Dept.
1800-736-6354 Ext. 360
Manufacturer Reason
for Recall		Contamination to in-vitro diagnostic test may result in false positives.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce106 kits (3,180 test)
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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