Recall Z-0251-2013 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
| Date | Nov 6, 2012 (initiated Nov 19, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 9 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.