CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report

Sunquest Laboratory recalled by Sunquest Information Systems

Sunquest Information Systems is recalling Sunquest Laboratory, distributed nationwide in the US. The recall was initiated on 3 Nov 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesnot available

Quantity recalled14 sites

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0250-2013
FDA event ID: 63369
Recalling firm: Sunquest Information Systems, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2011
FDA classified: 6 Nov 2012
Reported: 14 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Nov 2011	Recall initiated by company
6 Nov 2012	Classified by FDA	+369 days
14 Nov 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Product as listed by the FDA

Sunquest Laboratory, version 7.0 not available

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Ireland

Nationwide

Questions about this recall

Is Sunquest Laboratory recalled?

Yes. Sunquest Information Systems recalled Sunquest Laboratory on 3 Nov 2011. The recall is Class II and its status is Terminated. Recall number Z-0250-2013.

Why was it recalled?

Which lots are affected?

not available

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Ireland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sunquest Information Systems

All 9

Reported	Class	Recall	Company	Reason	Where
14 Nov 2012Device	CLASS II	Sunquest Application Interfacing Outbound Phlebotomy Point recalled	Sunquest Information Systems	Other	Nationwide
24 Oct 2012Device	CLASS III	Sunquest Laboratory : intended recalled by Sunquest Information Systems	Sunquest Information Systems	Device Malfunction	Nationwide
19 Sep 2012Device	CLASS II	Sunquest Laboratory Sunquest Laboratory is intended recalled	Sunquest Information Systems	Device Malfunction	Nationwide
5 Sep 2012Device	CLASS II	Sunquest Laboratory LabAccess Results Workstation (LARS) recalled	Sunquest Information Systems	Other	Nationwide
5 Sep 2012Device	CLASS II	Sunquest Laboratory Versions recalled by Sunquest Information Systems	Sunquest Information Systems	Device Malfunction	Nationwide

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