FDAClass IIIFebruary 20, 2019

Vergene Amplification Tray - 700uL recall

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the…

Why was Vergene Amplification Tray - 700uL recalled?

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

UDI: 00857573006287, Lots: 110318018C, 111018018D

Product
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the…
Recalling firm
Luminex Corporation
Quantity
1132 carriers
Distribution
Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Recall date
February 20, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls