CLASS III Device recall · Reported 24 Oct 2012 · FDA Enforcement Report
Sunquest Laboratory : intended recalled by Sunquest Information Systems
Sunquest Information Systems is recalling Sunquest Laboratory : intended for use by professionals working in a clinical laboratory, distributed nationwide in the US. The recall was initiated on 15 Nov 2011 and the FDA has classified it as Class III.
Check your package
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-0073-2013
- FDA event ID
- 62516
- Recalling firm
- Sunquest Information Systems, Tucson, AZ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2011
- FDA classified
- 17 Oct 2012
- Reported
- 24 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Nov 2011 | Recall initiated by company | |
| 17 Oct 2012 | Classified by FDA | +337 days |
| 24 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Where it was distributed
Nationwide distribution
Stores named: Online Retailers
Questions about this recall
Is Sunquest Laboratory : intended for use by professionals working in a clinical laboratory recalled?
Yes. Sunquest Information Systems recalled Sunquest Laboratory : intended for use by professionals working in a clinical laboratory on 15 Nov 2011. The recall is Class III and its status is Terminated. Recall number Z-0073-2013.
Why was it recalled?
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Which lots are affected?
Versions 6.4.0 and later
Where was it sold?
Nationwide distribution
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | Sunquest Application Interfacing Outbound Phlebotomy Point recalled | Sunquest Information Systems | Other | Nationwide |
| Device | CLASS II | Sunquest Laboratory recalled by Sunquest Information Systems | Sunquest Information Systems | Other | Nationwide |
| Device | CLASS II | Sunquest Laboratory Sunquest Laboratory is intended recalled | Sunquest Information Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Sunquest Laboratory LabAccess Results Workstation (LARS) recalled | Sunquest Information Systems | Other | Nationwide |
| Device | CLASS II | Sunquest Laboratory Versions recalled by Sunquest Information Systems | Sunquest Information Systems | Device Malfunction | Nationwide |
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
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