Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product… — Class III medical device recall Z-2229-2012
Terminated recall by Sunquest Information Systems, Inc., reported 2012-08-29, distributed nationwide. In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number as
| Recall number | Z-2229-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunquest Information Systems, Inc., Tucson, AZ, United States |
| Recall initiated | 2011-08-12 |
| Classified | 2012-08-20 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 47 sites |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2229-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.