FDA Medical Device Recalls (openFDA)
GE Healthcare Integrated IT Solutions: 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.
- Recall number
- Z-1397-2009
- Recalling firm
- GE Healthcare Integrated IT Solutions
- 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.
- Status
- Terminated
- Initiated
- 2008-11-17
- Posted
- 2009-05-15
- Terminated
- 2010-09-11
- Reason
- 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
- 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
- 26 units
- Distribution
- Worldwide Distribution -- USA and country of Canada.
- Lot, serial or model codes
- software version 7.3
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28