RecallRadar

FDA Device recall Z-2229-2012

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

On 2012-08-29 the FDA classified a Class III recall of Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use by Sunquest Information Systems, citing in GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2229-2012
ClassificationClass III
Statusterminated
Initiated2011-08-12
Published2012-08-29
Last updated2026-09-13 11:53 UTC
CompanySunquest Information Systems
DistributionUS

Product

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

Reason

In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Identifiers

code_infoVersion 6.4.2

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-2229-2012%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.