Z-0865-2014Class III

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

Name: Z-0865-2014 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 III and gives the reason as "GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal...". 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-0865-2014
Classification: Class III
Status: Terminated
Initiated: 2012-11-20
Posted: 2014-01-29
Terminated: 2016-05-16
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. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc
Root cause tag: software
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE CORRECTION letter date March 12, 2013 was sent to customers. The letter requests that customers review all calculated results to determine if either of the scenarios could occur at their site. If a customer determines that either of the scenarios proposed in the letter could occur at their site, the customer can contact their GE service representative to request or install the software update. Customers with questions can contact the GE Healthcare IT Helpdesk at 1-847-589-8496 or [email protected].
Quantity in commerce: 7 units
Distribution: Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
Product codes and lots: Software Versions: 3.3, 4.0, 4.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0865-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2014	Class III	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-29

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)