Clinisys Laboratory Solutions
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory…
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
7manufacturers in China registered for this device type
4catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | CliniSys, Inc, United States |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-02 |
| Record revised | 2024-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2024-08-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2023.2 | In distribution | |
| 2023.1 | In distribution | |
| 2023.2 | Withdrawn | |
| 2023.1.4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftLab | SCC Soft Computer | 64 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-03-15 | Class II | Software design | 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 (fo | 126 sites | 2012-10-02 |
| 2011-12-05 | Class II | Software design | 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 mi | 127 sites | 2012-08-27 |
| 2011-11-15 | Class III | Software design | 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 | 127 sites | 2012-10-19 |
| 2011-11-03 | Class II | Software design | 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. | 14 sites | 2012-11-06 |
| 2011-08-12 | Class III | Process design | 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. | 47 sites | 2012-09-04 |
| 2011-04-28 | Class III | Software design | 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 containe | 103 sites | 2012-09-04 |
| 2010-10-05 | Class II | Software design | 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. | 151 sites | 2012-08-24 |
| 2009-11-19 | Class II | Nonconforming Material/Component | 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. | 9 units | 2012-11-06 |
| 2009-04-13 | Class III | Software design | 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. | 23 clients | 2012-08-22 |
| 2008-08-01 | Not classified | Software design | 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 communic | 139 | 2011-11-28 |
| 2008-04-17 | Not classified | Component design/selection | 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 | 419 clients had the affected code | 2011-12-05 |
| 2005-09-29 | Not classified | Other | 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 instea | 67 | 2006-02-10 |
| 2005-05-13 | Not classified | Other | Software anomaly may rarely allow modification of previously reported specimen results. | 258 | 2006-02-10 |
| 2005-05-10 | Not classified | Other | 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. | 21 | 2005-08-30 |
| 2003-09-25 | Not classified | Other | Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. | 485 | 2004-09-03 |
| 2003-08-12 | Not classified | Other | Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review. | 479 | 2004-03-15 |
| 2003-07-24 | Not classified | Other | Software Design Defect. Under certain conditions, results are removed. | 47 | 2004-04-23 |
| 2003-07-23 | Not classified | Other | Software Defect. Data used in the diagnosis and or treatment of a patient’s illness are missing from the patient result report. | 466 | 2004-04-23 |
| 2003-07-22 | Not classified | Other | Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. | 171 | 2004-06-25 |
| 2003-07-21 | Not classified | Other | Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients. | 125 | 2004-11-15 |
| 2003-07-07 | Not classified | Other | 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. | 473 | 2004-09-23 |
| 2003-07-02 | Not classified | Other | Patient files become mixed up due to a software defect. | 1 | 2004-04-23 |
| 2003-06-23 | Not classified | Other | Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment. | 157 | 2004-04-23 |
| 2003-06-16 | Not classified | Other | Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment. | 315 | 2004-04-23 |
| 2003-06-10 | Not classified | Other | Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations. | 467 | 2004-04-23 |
| 2003-06-02 | Not classified | Other | Susceptibility comments are ommited from Microbiology cumulative reports | 471 | 2004-04-23 |
| 2003-05-13 | Not classified | Other | Two clients reported Quality Assurance dates could not be entered after 5/19/03. | 466 | 2004-04-23 |
| 2003-04-14 | Not classified | Other | Incorrect results could be filed. | 193 | 2004-04-21 |
| 2003-04-01 | Not classified | Other | Urgent care STAT reports are not printing in a timely fashion. | 109 | 2004-04-21 |
| 2003-03-26 | Not classified | Other | With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests. | 463 | 2004-04-21 |
| 2003-03-19 | Not classified | Other | Abnormal results are flagged as normal. | 1 | 2004-12-01 |
| 2003-02-28 | Not classified | Other | Patient results do not update properly when modified using on-line entry function. | 460 | 2004-06-02 |
| 2003-02-19 | Not classified | Other | Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry | 464 | 2004-06-02 |
| 2003-02-07 | Not classified | Other | Missing patient data on Location Chart Copy Cumulative Reports. | 478 | 2004-06-02 |
| 2003-02-06 | Not classified | Other | Two customers report that the organism identified on the patient’s lab file do not match the reported susceptibility battery. | 465 | 2004-05-07 |
| 2003-01-31 | Not classified | Other | Software anomaly. Patient results may be filed in the incorrect patient file | 542 | 2004-07-14 |
| 2003-01-31 | Not classified | Other | Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. | 542 | 2004-05-07 |
| 2003-01-17 | Not classified | Other | Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol. | 520 | 2004-05-07 |
| 2002-12-20 | Not classified | Other | An incorrect collection date and time may be accepted and filed to the patient file. | 465 | 2004-12-01 |
| 2002-12-20 | Not classified | Other | Software anomally. English text code does not translate. | 26 | 2004-04-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.