FDAClass IIMay 9, 2018

AQURE, Software version 2.3.0 and 2.3.1 Product Usage recall

AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator…

Why was AQURE, Software version 2.3.0 and 2.3.1 Product Usage recalled?

There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.

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?

Version 2.3.0 and 2.3.1

Product
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator…
Recalling firm
Radiometer Medical ApS
Quantity
2
Distribution
US Nationwide Distribution in the states to Georgia and Wisconsin.
Recall date
May 9, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls