Luminex Corporation VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 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
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Brand
Luminex Corporation
Lot Codes / Batch Numbers
Lot Number 101321021B
Products Sold
Lot Number 101321021B
Luminex Corporation is recalling VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 due to Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Recommended Action
Per FDA guidance
Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory.
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