FDA Devices recall · Reported August 22, 2012
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
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…
Sunquest Information Systems, Inc. recalled Sunquest Laboratory SMART & Sunquest Laboratory SMART Select - a low-severity action.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select was recalled by Sunquest Information Systems, Inc. in August 22, 2012. Reason: In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on an…. Check the official notice for the remedy. Verify recall #Z-2216-2012 with the FDA Devices before acting.
The recall
Sunquest Information Systems, Inc. issued this low-severity FDA Devices recall-In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on an….
- Low
- severity level
- Class III
- classification
- August 22, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2216-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2216-2012 |
| Date reported | August 22, 2012 |
| Date initiated | April 28, 2011 |
| Recalling firm | Sunquest Information Systems, Inc. |
| Firm location | Tucson, AZ |
| Affected scope | 103 sites |
| Distribution | Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2216-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026