FDAClass IISeptember 5, 2012

Sunquest Laboratory LabAccess Results Workstation recall

Sunquest Laboratory LabAccess Results Workstation (LARS)

Why was Sunquest Laboratory LabAccess Results Workstation recalled?

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.

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?

Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3

Product
Sunquest Laboratory LabAccess Results Workstation (LARS)
Recalling firm
Sunquest Information Systems, Inc.
Quantity
151 sites
Distribution
Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls