Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
FDA device recall Z-0251-2013 · posted 2012-11-06 · Terminated
Recall details
- Recalling firm
- Sunquest Information Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 9 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-11-19
- Date posted
- 2012-11-06
- Date terminated
- 2012-11-06
- Location
- Tucson, AZ
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