Sunquest Laboratory Versions 6 — Class II medical device recall Z-2270-2012
Terminated recall by Sunquest Information Systems, Inc., reported 2012-09-05, distributed nationwide. The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later wh
| Recall number | Z-2270-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunquest Information Systems, Inc., Tucson, AZ, United States |
| Recall initiated | 2011-12-05 |
| Classified | 2012-08-24 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 127 sites |
| Reason classes | microbial contamination |
Product
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Reason for recall
The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
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-2270-2012. 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.