Z-1585-2013Class II

The Centricity Laboratory System is intended to be an information system designed to support the clinical and...

Name: Z-1585-2013 The Centricity Laboratory System is intended to be an information system designed to support the clinical and...
Creator: GE Healthcare It
Published: 2012-11-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-11-20 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the... on 2012-11-20. FDA classified it as Class II and gives the reason as "If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages...". 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-1585-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-20
Posted: 2013-06-24
Terminated: 2016-06-10
Recalling firm: GE Healthcare
Product: The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000
Quantity in commerce: 9 Units
Distribution: Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
Product codes and lots: Software Versions 3.3, 4.0, and 4.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1585-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)