FDAClass IIMay 25, 2022

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray recall

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

Why was VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 101321021B

Product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Recalling firm
Luminex Corporation
Quantity
984 units
Distribution
US
Recall date
May 25, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls