Verigene Blood Culture Test (Luminex) – Test Result Risk (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Luminex Corporation
Lot Codes / Batch Numbers
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Products Sold
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Luminex Corporation is recalling VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sam due to 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 cart. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.)."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026