Data Foundry

Medical device recalls 2012

Sunquest Laboratory — Class II medical device recall Z-0250-2013

Terminated recall by Sunquest Information Systems, Inc., reported 2012-11-14, distributed nationwide. Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episod

Recall numberZ-0250-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSunquest Information Systems, Inc., Tucson, AZ, United States
Recall initiated2011-11-03
Classified2012-11-06
Reported by FDA2012-11-14
Terminated2012-11-06
DistributedNationwide (US)
Countries outside the USIE
Quantity14 sites

Product

Sunquest Laboratory, version 7.0 not available

Reason for recall

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

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-0250-2013. 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.