CliniSys, Inc
Tucson, AZ, US
CliniSys, Inc appears in FDA device records in Tucson, AZ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 48 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to CliniSys, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Misys Healthcare Systemsrecall
- Sunquest Information Systems, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2029302 | 1000306472 | CliniSys, Inc | 3300 E. Sunrise Dr., TUCSON, AZ 85718 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 48| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2332-2012 | Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide. | Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event | Class II | Terminated | |
| Z-2270-2012 | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry | The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information. | Class II | Terminated | |
| Z-0073-2013 | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10. | Class III | Terminated | |
| Z-0250-2013 | Sunquest Laboratory, version 7.0 not available | Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. | Class II | Terminated | |
| Z-2229-2012 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use | In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive. | Class III | Terminated | |
| Z-2216-2012 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select | In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or | Class III | Terminated | |
| Z-2272-2012 | Sunquest Laboratory LabAccess Results Workstation (LARS) | The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results. | Class II | Terminated | |
| Z-0251-2013 | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. | 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. | Class II | Terminated | |
| Z-2243-2012 | Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. | Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active. | Class III | Terminated | |
| Z-0214-2009 | Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data. | While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache)was not communicated or displayed in the Graphic User Interface (GUI) application so the activity continued. While this error was registered in the error log in the System U | Terminated | ||
| Z-0207-2009 | 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 containers from order to final disposition 3) Monitor key metrics such as turnaround time and utilization using management reports 4) Produce pathology results with Structured Reports 5) Suggest microbiology workups online according to defined SOPs and rules 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools 7) Any change to patient results (inquiry, reports) is logged and available for review | 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 | Terminated | ||
| Z-0088-06 | Misys Laboratory version 6.1 - Microbiology Module | Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000. | Terminated | ||
| Z-0938-05 | Misys Laboratory with Lab Access Results application for versions 5.3 and later. | Software anomaly may rarely allow modification of previously reported specimen results. | Terminated | ||
| Z-0939-05 | Mysis Laboratory version 6.1 | When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted. | Terminated | ||
| Z-0235-04 | Calculator/ Data Processing Module for Clinical Use. | Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. | Terminated | ||
| Z-0007-04 | Calculator/Data Processing Module for Clinical Use | Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review. | Terminated | ||
| Z-1220-03 | Calculator/ Data Processing Module for Clinical Use | Software Design Defect. Under certain conditions, results are removed. | Terminated | ||
| Z-1240-03 | Calculator/ Data Processing Module for Clinical Use | Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report. | Terminated | ||
| Z-1217-03 | Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results | Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. | Terminated | ||
| Z-0238-04 | Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results. | Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients. | Terminated | ||
| Z-0151-04 | Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2. | Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. | Terminated | ||
| Z-1092-03 | Misys Laboratory System version 5.3 | Patient files become mixed up due to a software defect. | Terminated | ||
| Z-1093-03 | Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. | Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment. | Terminated | ||
| Z-1090-03 | Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module | Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment. | Terminated | ||
| Z-1007-03 | Misys Laboratory System, versions 5.2, 5.23 and 5.3 | Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain