GE Healthcare Integrated IT Solutions GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Brand
GE Healthcare Integrated IT Solutions
Lot Codes / Batch Numbers
Software versions 3.3.2.27_P4 and 4.0.1_SP.x
Products Sold
Software versions 3.3.2.27_P4 and 4.0.1_SP.x
GE Healthcare Integrated IT Solutions is recalling GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab res due to Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.
Recommended Action
Per FDA guidance
GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026