Recall Z-2067-2026 ยท QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
BioFire Diagnostics, LLC
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
| Date | May 6, 2026 (initiated Apr 22, 2026) |
| Status | Open, Classified |
| Reason | Contamination to in-vitro diagnostic test may result in false positives. |
| 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 I |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.