FDA Device recall Z-2216-2012
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- FDA Device
- Class III
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class III recall of Sunquest Laboratory SMART & Sunquest Laboratory SMART Select by Sunquest Information Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2216-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-04-28 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sunquest Information Systems |
| Distribution | US |
Product
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Reason
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
Identifiers
| code_info | Version 6.3.0 and Later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2216-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.