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Open, Classified

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

FDA Recall Z-2067-2026 · Posted 2026-05-06

Recalling FirmBioFire Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeQSN
Date Initiated2026-04-22
Product Quantity106 kits (3,180 test)

Reason for Recall

Contamination to in-vitro diagnostic test may result in false positives.

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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