Recall Z-0823-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single loca
| Date | Jan 24, 2014 (initiated Oct 30, 2013) |
| Status | Terminated |
| Reason | Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.) |
| Root cause | Software design |
| Action | The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated October 23, 2013 to its customers. The firm also sent a follow-up letter dated October 30, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed Until a service visit is scheduled, do the following: Instruct the laboratory staff to recognize this sequence of events and Ensure that whenever the operator disables a method on an Aptio system or a CentraLinksystem and replenishes reagent for that method, the operator then confirms that the method remains disabled in the C |
| Quantity | 40 |
| Distribution | US Distribution in the states of: MN, NJ, and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.