Recall Z-0330-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
GE Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mai
| Date | Nov 15, 2013 (initiated Mar 12, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the ma |
| Root cause | Software design |
| Action | GE Healtchare sent an Urgent Medical Device Correction letter dated March 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers review their workflows to determine whether this series of events could happen at their sites. Customers who self-identified this series of events as a possible workflow are recommended to contact their GE service representative for a software correction. These customers may also elect to identify master panels that may be re-routed ad hoc and then to ensure |
| Quantity | 7 units |
| Distribution | Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.