Sunquest Laboratory : intended for use by professionals working in a… — Class III medical device recall Z-0073-2013
Terminated recall by Sunquest Information Systems, Inc., reported 2012-10-24, distributed nationwide. Online calculations may not be performed as expected or may yield results that are different than expected whe
| Recall number | Z-0073-2013 |
|---|---|
| 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 | 2011-11-15 |
| Classified | 2012-10-17 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2012-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 127 sites |
Product
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Reason for recall
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.
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-0073-2013. 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.