Sunquest Information Systems, Inc. Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Brand
Sunquest Information Systems, Inc.
Lot Codes / Batch Numbers
v3.0.0_07222004 and later
Products Sold
v3.0.0_07222004 and later
Sunquest Information Systems, Inc. is recalling Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and la due to The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combinin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Recommended Action
Per FDA guidance
Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.
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