Z-2067-2026Class II

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

Name: Z-2067-2026 BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
Creator: BioFire Diagnostics, LLC
Published: 2026-04-22
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2026-04-22 / Open, Classified

FDA source

BioFire Diagnostics, LLC began a recall of BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit on 2026-04-22. FDA classified it as Class II and gives the reason as "Contamination to in-vitro diagnostic test may result in false positives". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2067-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-22
Posted: 2026-05-06
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Product code: QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Reason for recall: Contamination to in-vitro diagnostic test may result in false positives.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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.
Product codes and lots: Lot #s:0883425,0878825/DI: 00815381020192

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2067-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code QSN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)