GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used 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
- Recall Number
- Z-2067-2010
- Event Number
- 55868
- Firm
- Ge Healthcare It
- FEI Number
- 3004526608
- Product Code
- JQP
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 26, 2010
- Terminated
- July 15, 2011
- Address
- 540 W Northwest Hwy, Barrington, IL, 60010-3051
Description
GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used 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.
There is a potential safety issue associated with the use of GE Centricity Laboratory software where results from interfaced external reference laboratories are not displayed or stored correctly. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the test result sent from the reference lab includes a comma in the result field.
The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated May 26, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue involving results from interfaced external reference laboratories that are not displayed or stored correctly if an unexpected alpha character is encountered in a result message that is expected to have a numeric value. This happens when the test is set up in Centricity Laboratory as a decimal (numeric) type result and the result sent from the reference lab includes a comma in the result field. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to the their GE Service Representative or the GE Helpdesk at 888-778-3375.
Worldwide distribution: California, Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee and Texas, and internationally to Australia, Canada, China, England, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
37 units