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

FDA device recall Z-2067-2026 · posted 2026-05-06 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

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

Action taken

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

Status

Open, Classified

Product code

QSN

Quantity affected

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, Fi

Date initiated

2026-04-22

Date posted

2026-05-06

Location

Salt Lake City, UT