CLASS III Device recall · Reported 22 Aug 2012 · FDA Enforcement Report
Sunquest Laboratory Smart & Sunquest Laboratory Smart Select recalled
Sunquest Information Systems is recalling Sunquest Laboratory Smart & Sunquest Laboratory Smart Select, distributed nationwide in the US. The recall was initiated on 28 Apr 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-2216-2012
- FDA event ID
- 62344
- Recalling firm
- Sunquest Information Systems, Tucson, AZ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Apr 2011
- FDA classified
- 16 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Apr 2011 | Recall initiated by company | |
| 16 Aug 2012 | Classified by FDA | +476 days |
| 22 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
Product as listed by the FDA
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Where it was distributed
Nationwide Distribution
Stores named: Online Retailers
Questions about this recall
Is Sunquest Laboratory Smart & Sunquest Laboratory Smart Select recalled?
Yes. Sunquest Information Systems recalled Sunquest Laboratory Smart & Sunquest Laboratory Smart Select on 28 Apr 2011. The recall is Class III and its status is Terminated. Recall number Z-2216-2012.
Why was it recalled?
In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
Which lots are affected?
Version 6.3.0 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 III | Sunquest Laboratory : intended recalled by Sunquest Information Systems | Sunquest Information Systems | Device Malfunction | 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 |
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| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |