Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 29, 2012
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sunquest Information Systems, Inc. recalled Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clini… - a low-severity action.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clini… was recalled by Sunquest Information Systems, Inc. in August 29, 2012. Reason: In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number a…. Check the official notice for the remedy. Verify recall #Z-2229-2012 with the FDA Devices before acting.
The recall
Sunquest Information Systems, Inc. issued this low-severity FDA Devices recall-In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number a….
- Low
- severity level
- Class III
- classification
- August 29, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2229-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2229-2012) was formally reported on August 29, 2012, with the manufacturer initiating the action on August 12, 2011. It is classified under Low severity (Class III), with a current status of Terminated. Sunquest Information Systems, Inc. is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 47 sites.
The documented reason for this recall is: In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive. Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
47 sites
Related Recalls
6
3 from same agency
Product description
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Reason for recall
In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2229-2012 |
| Date reported | August 29, 2012 |
| Date initiated | August 12, 2011 |
| Recalling firm | Sunquest Information Systems, Inc. |
| Firm location | Tucson, AZ |
| Affected scope | 47 sites |
| Distribution | US 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-2229-2012) 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.
Frequently Asked Questions
What product was recalled? ▼
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use. Recalled by Sunquest Information Systems, Inc.. Units affected: 47 sites.
Why was this product recalled? ▼
In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Low. Recall number: Z-2229-2012.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2229-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 29, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.