Luminex Corporation Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests. Recall
Hazard assessment based on recall description.
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
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Brand
Luminex Corporation
Lot Codes / Batch Numbers
Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
Products Sold
Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
Luminex Corporation is recalling Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, due to Potentially defective utility trays in the reagent kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potentially defective utility trays in the reagent kits.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 11/7/2023 via email on the same date. The letter explained the reason for recall, risk to health, and actions to be taken by the consignee/distributor. The actions included examining their inventory for the affected product, cease all use, and isolate or quarantine the product pending disposal; contact Luminex Global Support Services to arrange for replacement and confirm the disposal of any remaining kits in inventory; perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) and if false negative results with a patient sample tested with the affected lot number have been encountered, contact Luminex Global Support; distribute the notification to any individuals within their organization who need to be made aware of the recall; if the consignee is a distributor, they are to provide a copy of this letter to any customers or organizations who may have received the affected lot number; and complete the enclosed Acknowledgement & Receipt Form and return it to Luminex Technical Support.
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