Z-2270-2012Class II

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Name: Z-2270-2012 Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Creator: Sunquest Information Systems, Inc.
Published: 2011-12-05
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2011-12-05 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry on 2011-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2270-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-05
Posted: 2012-08-24
Terminated: 2012-08-27
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: Sunquest sent a recall letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your reply to this email message serves as verification you have received, read, understood and/or followed instructions outlined in the attached Product Safety Notification. Your reply assists Sunquest Information Systems to satisfy our obligation to Regulatory Agencies. Please note in your email reply if your site will not be requesting the software correction. If your site plans to request the software correction, please follow the directions noted on the attached PSN. Further questions please call (520) 570-2347.
Quantity in commerce: 127 sites
Distribution: Worldwide Distribution -- USA (nationwide) and the country of Canada.
Product codes and lots: Versions 6.4 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2270-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2270-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-24

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)