RecallDepth

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Company
Luminex Corporation
Recall Initiated
February 15, 2022
Recall Number
Z-1109-2022
Quantity
984 units
Firm Location
Northbrook, IL

Reason for Recall

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

Distribution

US

Lot / Code Info

Lot Number 101321021B

Root Cause

Under Investigation by firm

Action Taken

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.

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