Recall Z-0207-2009 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: 1) Autoverify results directly from analyzers and reference laboratories 2) Track tubes and cont
| Date | Oct 31, 2008 (initiated Apr 17, 2008) |
| Status | Terminated |
| Reason | Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat |
| Root cause | Component design/selection |
| Action | Customers were sent a preliminary notice on 4/17/2008 followed by customer notice PSN-08-04 on 05/07/2008 via email. The notice advises that this notice is follow-up to the Preliminary notice distributed on 4/17/08 and applies to all clients who have an Instrument Generated Order (IGO) interface. Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the pati |
| Quantity | 419 clients had the affected code |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.