Z-1397-2009

Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010...

Name: Z-1397-2009 Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-11-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-11-17 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a... on 2008-11-17. The reason FDA records is "A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than 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-1397-2009
Status: Terminated
Initiated: 2008-11-17
Posted: 2009-05-15
Terminated: 2010-09-11
Recalling firm: GE Healthcare
Product: Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.
Quantity in commerce: 26 units
Distribution: Worldwide Distribution -- USA and country of Canada.
Product codes and lots: software version 7.3

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)