Sunquest Laboratory SMART & Sunquest Laboratory SMART Select — Class III medical device recall Z-2216-2012
Terminated recall by Sunquest Information Systems, Inc., reported 2012-08-22, distributed nationwide. In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on ano
| Recall number | Z-2216-2012 |
|---|---|
| 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 | 2011-04-28 |
| Classified | 2012-08-16 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2012-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 103 sites |
Product
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
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-2216-2012. 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.