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Open, Classified

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

FDA Recall Z-1109-2022 · Posted None

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodePEP
Date Initiated2022-02-15
Product Quantity984 units

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.

Firm Action

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 [email protected] to arrange for replacement and confirm the disposal of any kits in inventory.

Root Cause

Under Investigation by firm

Distribution Pattern

US

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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