FDA Device recall Z-0073-2013
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory
- FDA Device
- Class III
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class III recall of Sunquest Laboratory : intended for use by professionals working in a clinical laboratory by Sunquest Information Systems, citing online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) applic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0073-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-11-15 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sunquest Information Systems |
| Distribution | US |
Product
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Reason
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Identifiers
| code_info | Versions 6.4.0 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-0073-2013%22
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