Z-2671-2016Class II

Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information...

Name: Z-2671-2016 Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information...
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 Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and... on 2012-11-20. FDA classified it as Class II and gives the reason as "The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel...". 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-2671-2016
Classification: Class II
Status: Terminated
Initiated: 2012-11-20
Posted: 2016-08-26
Terminated: 2017-12-29
Recalling firm: GE Healthcare
Product: Centricity Laboratory Core Lab System 4.1 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071. Customers were instructed to contact their GE Service Representative with any questions regarding this issue. For other questions, contact GE Helpdesk: North America; (905) 479-1249 or 1-888-778-3375; email: [email protected] Europe; +44 1603 877595; email: [email protected] Asia Pacific; +61 3 5327 4000; email: [email protected]. For questions regarding this recall call 847-277-5000.
Quantity in commerce: 17
Distribution: Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
Product codes and lots: Versions 4.1, 4.0, 3.3.2 & 3.3Almp

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2671-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2671-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26

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)