Recall Z-1903-2025 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
| Date | Jun 3, 2025 (initiated Apr 16, 2025) |
| Status | Completed |
| Reason | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. |
| Root cause | Under Investigation by firm |
| Action | Diasorin issued an Urgent Field Safety Notice to its consignees on 04/16/2025 via email. The notice explained the issue, potential risk to health, and requested the following: "Actions to be taken by the Customer/User 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected barcode serial numbers from VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A, please contact Technical Support at support@luminexcorp.com to arrange for replacement and confirm the disposal |
| Quantity | 89 units |
| Distribution | US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) Nanosphere, Inc., Jan 8, 2014 |