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
- Company
- Luminex Corporation
- Recall Initiated
- April 16, 2025
- Posted
- June 3, 2025
- Recall Number
- Z-1903-2025
- Quantity
- 89 units
- Firm Location
- Northbrook, IL
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Lot / Code Info
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Root Cause
Under Investigation by firm
Action Taken
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 of any remaining tests in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN). If you have encountered a false negative result with a patient sample tested with the potentially impacted portion of Lot 022525021A, please contact Technical Support at support@luminexcorp.com. 5. If you are a distributor, provide a copy of this letter to any customers or organizations who may have received VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A. 6. Please complete the Acknowledgement & Receipt Form and return it to Technical Support. 7. For those with complaints, questions, or concerns please contact Technical Support at 1-877-785-2323 (U.S) or +1-512-381-4397 (Outside U.S.)."