Class 1 device recall spotchem ii basic panel test strips. All prices are quoted net of the statutory valueadded tax and shipping costs and possibly delivery charges, if not otherwise described. The development of the spotchem ez started to achieve this. The firm sent an urgent medical device recall letter to customers beginning on december 18, 2015. Although the whole blood is placed on the instrument, the measurement is from plasma because there is a centrifuge on the spotchem ez sp4430 that separates the whole blood, and the plasma is then analyzed.
Arkray spotchem ii chemistry basic ii is intended for the in vitro quantitative determination of alp, ast. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mgdl, there is a risk that the health care provider would not diagnose hyperglycemia high blood sugar. Fast, accurate and simple electrolyte analysis of body fluidsessential in an emergency. Arkray spotchem ez chem analyzer wb polymedco, inc 82040qw genzyme diag osom immunodip urinary alb genzyme diagnostics 82040qw hemocue albumin 201 system urinary albumin hemocue ab 82040qw teco diagnostics, albumin rapid test stick and card teco diagnotics 82040qw alanine aminotransferase alt. Spotchem ez is a mostadvanced dry chemistry analyzer. We have 1 arkray spotchem ez sp4430 manual available for free pdf download. Arkrays mission is to contribute to the health and. With units installed on top of one another, it takes up very little space too. Both analyses were performed with the spotchem ez sp 4430 arkray, scil, holtzheim, france within 30 min. Spotchem ez instrument specifications processing speed x 48 samples per hour minimum sample volume x 250 l measurement wavelength x 5 wavelengths 405, 550, 575, 610 and 820 nm. Configuring the scil spotchem ez for transmission to configure the spotchem ez for transmission.
Spotchem dconcept d02 instruments clinical chemistry. In order to calculate trueness, 20 patient serums were studied on spotchemez and bs800m autoanalyzer. The spotchem ez accepts whole blood or serum samples and is calibrated automatically with the swipe of a magnetic card. Electrolyte analyzer with ionselective electrodes se1520 minute samples whole blood, serum, plasma apd uriae can be measured with very small samplesonly 22 ul. Comparison of measurements of canine plasma creatinine. This product is intended for use with the spotchem ez analyzer sp4430.
Arkrays mission is to contribute to the health and wellbeing of people all over the world through the advancement of science and the discovery of new technologies. Cardinalhealth sells and distributes arkray laboratory equipment, reagents, and consumables for the aution max ax4030 automated urine chemistry analyzer and aution hybrid au4050 fullautomated and integrated urine chemistry and sediment analyzer. Run single tests or full panels at a fraction of the cost of other analysers. Awarded the 1st prize for promoting machine industry for spotchemez. The instrument features an onboard centrifuge, requires no sample pretreatment, and is lightweight and portable for easy transport. Verification of some biochemistry tests that to be analyzed. Consult arkrays spotchem ez sp4430 brochure on medicalexpo. Spotchem ez sp4430 lets build an automatic drychemistry device that is smaller, faster and cheaper. The spotchem ez is a small, portable, clia waived bench top chemistry analyzer that utilizes dry chemistry technology. One lot each of spotchem ii basic panel1 reagent test strip and spotchem ii glucose reagent test strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. Arkray supplies multiparameter urine test strips, consumable products, and. Dry clinical chemistry analyzer the small, efficient and proven allrounder.
Spotchem sp4430 chemistry analyser the spotchem sp4430 is an easy to use benchtop analyser that features automated, hands free pipetting and the lowest chemistry testing costs on the market. Both analysis modules can each carry out 12 fully automated clinical chemistry analyses. The easy to use, automated hemoglobin a1c analyzer with diagnosis claims employs gold standard hplc technology. As a qualified veterinary practice assistant, and animallover, i am delighted that microbiology, urine diagnosis, haematology and clinical chemistry are not only important aspects of axonlabs work in human medicine, but that it holds a diagnostics portfolio for veterinarians as well, and that i can travel on behalf of axonlab as a sales account manager in the veterinary field. In order to put it into practice, we set about distributing questionnaires to each and every domestic customer. Automated analyzer for clinical chemistry spotchem ez sp4430. We provide the veterinary supplies a clinic needs to support topnotch care in companion animal health. Arkray develops products that focus on diabetes testing and urinalysis in addition to other simple test equipment that supports both medical professionals and patients alike. The easy to use analyzer reduces operator variability, while optimizing laboratory. New arkray spotchem ez sp4430 chemistry analyzer for sale. This product is intended for use with the spotchem ez analyzer.
Spotchem ii kenshin2 reagents clinical chemistry human. Optimize workflow with true walkaway automated urinalysis maximize your laboratory performance with the aution hybrid au4050. Arkray spotchem ez sp4430 operating manual pdf download. Oct 08, 2015 benchtop dry chemistry analyzer for whole blood or serum samples for both the human and veterinary markets. The developing team members had many discussions on the idea of completely standardizing the parts designed for each model such as the operation part, printer, communication, which had been. Arkray introduced the first fully automated hplc hemoglobin analyzer in 1981 and has built upon the technology to meet the needs of todays user. Menarini diagnostics austria home laborprodukte download. The affected lots will display a result of approximately 300 to 400 mgdl for any glucose value that exceeds the upper limit of 416 mgdl. Spotchemez arkray device on the base of clsi, ep15a2 guidelines for glucose, bun, ast, alt, tbil, total cholesterol, and calcium tests. We offer a comprehensive selection of veterinary products, supplies and services for the equine veterinary practice. Aution hybrid au4050 arkray usa clinical diagnostics. New arkray spotchem ez sp4430 chemistry analyzer for. It was studied on spotchemez device in a way that there were to be 2.
Benchtop dry chemistry analyzer for whole blood or serum samples for both the human and veterinary markets. A builtin compact centrifuge reduces pretreatment of samples before measurement. In order to calculate trueness, 20 patient serums were studied on spotchem ez and bs800m autoanalyzer. Postacquisition inhospital training, continuing education, support and service make the critical difference to the ongoing performance of the instrument. The system can run panels, single tests or a combination so you can test the way you need to. Arkrays response to coronavirus covid19 learn more diabetes management. And, calibration is completed in seconds with the swipe of a magnetic card. Spotchem ez sp4430 measuring instruments pdf manual download. Automated analyzer for clinical chemistry spotchem ez.
This manual contains outlines, instructions for the operation, maintenance and troubleshooting for the spotchem sp4430. We understand that quality products are not enough in todays modern veterinary laboratory. Measuring instruments arkray aution max ax4030 operating manual 206 pages. The spotchem ez is easy to use load consumables, press start, and walk away. Arkray clinical diagnostics supports the united states healthcare market with fully automated urine analyzers and automated dry chemistry analyzers for healthcare and veterinary laboratories. The letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm. Create your own chemistry panels by adding single tests. The spotchem dconcept was developed to change the face of poct. Spotchem ez basic panel 1 test strips stat technologies. Stateoftheart technology lies beneath this elegant surface, starting from the control module right down to individual analysis modules.
Download company profile pdf history of pioneers near patient testing. View online or download arkray aution max ax4030 operating manual. View and download arkray spotchem ez quick instruction manual online. Spotchem ez performs biochemical measurements easily with the dry method and solid phase reagent. Before operating the sp4430, read this manual carefully. Arkray spotchem ez sp4430 manuals manuals and user guides for arkray spotchem ez sp4430. As a comparative device for the bias calculation, mindraybs800m device which is the current autoanalyzer was used. Verification of some biochemistry tests that to be. The efficiency of the builtin centrifuge was tested in 10 unselected canine liheparin blood samples and corresponding plasmas after 5 min centrifugation at 3000g hettich eba 3s, tuttlingen, germany. Spotchem dconcept the development of the spotchem dconcept began with an idea to create a common platform for various medical testing devices. Arkray supplies multiparameter urine test strips, consumable products, and clinical chemistry reagents. Arkray is recalling the spotchem ii basic panel1 reagent test strip and spotchem ii glucose reagent test strip because they may report falsely low blood glucose levels.
Awarded the 1st prize for promoting machine industry for spotchem ez. Menarini diagnostics belgio home producten voor laboratoria. It was studied on spotchemez device in a way that there were to be 2 two level internal quality control as three times and repetitive for 5 five days, in order to calculate precision on above designated tests. Cardinalhealth is a health services company that specializes in the distribution of medical. View and download arkray spotchem ez sp4430 operating manual online. The spot chem ez analyzer is a small, portable, clia waived bench top chemistry analyzer that utilizes dry chemistry technology. This instrument comprises all the functions demanded from the market and allows customization according to function. Arkray spotchem ez quick instruction manual pdf download. The analyzer builds on proven technology to generate quality results, improve outcomes and provide superior precision to accurately report hba1c. It was studied on spotchem ez device in a way that there were to be 2 two level internal quality control as three times and repetitive for 5 five days, in order to calculate precision on above designated tests. The spotchem ez development started with questionnaires. Arkray heska spotchem ez sp4430 clinical chemistry analzyer.
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