It is designed to provide answers to your questions about the meters operation and use. Alere starts voluntary correction about use of alere. Fitlinxx alere airlink for inratio irb fcc id o9dirb. User manuals, guides and specifications for your dymo inratio printer printer. Alere determine tb lam ag screen in just 25 minutes for hivassociated tb. The inratio2 monitor represents the latest from hemosense in ptinr testing at home. San diego, california, march 2, 2017 a new lawsuit alleges the alere inratio blood monitoring system used by patients taking bloodthinners like warfarin, produces erroneous results, which can lead to serious injury or death a group of plaintiffs from across the u. This action is a result of complaints of patients who had a. View and download inverness medical inratio2 user manual online. Alere inratio ptinr monitor system therapeutic goods. Alere toxicology offers drug testing products and services that are used in a multitude of settings such as hospitals, clinics, physician offices, criminal justice, workplace, rehabilitation, occupational health clinics, and home testing. Alere dds 2 a novel approach to drugs of abuse screening. The contents of this manual, including all graphics and photographs, are the property of.
Start the printer ensure the power adapter and the data cables are correctly connected. The user manual also explains how the analyzer works, describes the quality assurance system and assists you in troubleshooting. Upon arrival of your afinion 2 analyzer we recommend that the serial number along with the software version be recorded in the table provided below. This coaguchek xs system user manual is a comprehensive guide to the meter. Alere to initiate voluntary withdrawal of the alere inratio. Alere q hiv12 detect accessible, molecular testing in.
Alere hemopoint h2 system direct from new line medical. Irb alere airlink for inratio user manual users guide, v 1. Alere to initiate voluntary withdrawal of the alere inratio and inratio2 ptinr monitoring system news provided by. Inratio2 ptinr professional test strips package insert alere inratio2 ptinr professional test strips alere inratio2 ptinr professional test strips for use with the alere inratio2 professional testing kit please read all of the information in this package insert and in the alere inratio2 ptinr professional testing kit user guide. Blood analysis system the right result at the right time. Inratio2 allows you to obtain your prothrombin time pt and international normalized ratio inr results in less than a minute using 1 drop of blood from a fingerstick.
Field testing of the alere dds2 mobile test system for drugs in oral fluid. Alere inratio2 ptinr heparininsensitive test strips. Class i is the most serious type of recall for medical devices because use of such devices will likely result in serious injury or death to the user. Alere determine hiv12 agab combo quick reference card. Alere i delivers labaccurate results faster than any other molecular method. Dear valued customers, alere released an urgent recall in regards to the hemosense inratio and inratio 2 ptinr monitoring systems and their test strips. Please fax the completed form to 18886566380 or email a pdf to.
Alere hemopoint h2 user manual 4 intended use the alere hemopoint h2 system is intended for the quantitative determination of hemoglobin hgb in whole blood of adults, infants, and children in a professional pointofcare setting. Product exclusively available for export to select markets. Class 1 device recall alere inratio inratio2 ptinr test strips. Press the key to power the alere triage meterpro on. Alere starts voluntary correction about use of alere inratio. Under no circumstances should you open the ac power adaptor. Inratio2 allows you to obtain your prothrombin time pt and international normalized ratio inr results in less than a minute. Both of the 2014 recall alerts for the alere inratio ptinr monitor system and test strips were classified as class i recalls. Alere hiv combo 4th generation, delivering results in just 20 minutes.
Guides the user through running tests, recalling results and deleting results. This action is being initiated as a result of patients who had a therapeutic or neartherapeutic inr with the alere inratio. Insert the data cable to the suitable interface on the back of the printer, and fixed it with a screw or clip spring. Alere initiates voluntary urgent correction for use of alere. Intended use the inratio2 pt monitoring system is used for the quantitative measurement of prothrom. Test strip package inserts be sure to read the test strip package insert for important. Alere determine syphilis tp accurate syphilis results in 15 minutes. You must complete proper training on the inratio2 pt monitoring system before you begin using the system.
Before alere owned the inratio monitor, ownership of the medical device changed many hands. Alere inratio2 method and sample collection method ie. Class 1 device recall alere inratio inratio2 ptinr test. The alere triage meterpro user manual is divided into five sections.
Alere inratioinratio2 alere pdf catalogs technical. Companies that assist patients in getting an inr home monitoring instrument name of company supports which instruments. Inratio 2 ptinr assistance or additional information. Monitoring system user manual is to help you understand your.
Pdf field testing of the alere dds2 mobile test system for. Alere manufacturing is written in visual foxpro and. An html help manual has support down to the field level for the user. Reply form i have been notified by alere san diego, inc. Alere inratio 2 prothrombin timeinr monitoring system test.
Connect other end of the communication cable to the testing device. Customizations using the tiw developers kit, can minimize the effort if any of moving to a new release, preserving your investment. The inratio 2 pt monitoring system is used for the quantitative measurement of prothrom bin time pt in fresh, capillary whole blood. Alere san diego is initiating a voluntary recall for the alere inratio. T he alere inratio ptinr monitor system was developed and marketed by san jose, californiabased biotechnology firm hemosense. Patients who used an alere inratio device to monitor their blood are filing lawsuits after test results lead to false positives causing serious injuries and even death. Prothrombin timeinr test strips for use with the alere inratio2 pt. Coagsense pt2 ptinr selftest system 1 box promotion for. Alere determine hiv 12 agab combo quick reference card clia complexity. Pdf field testing of the alere dds2 mobile test system. In a few minutes the results will appear on the screen. Alere plans to remove the inratio and inratio2 ptinr.
The coagsense prothrombin time ptinr system is used for. When turning on the power the green led will be on and the red led off. Please shop under the category inratio inr products to see other brands on our website. In december 2014, alere issued a recall of its inratio and inratio2 ptinr monitor systems after receiving almost 19,000 complaints, including three deaths. User manual this coaguchek xs system user manual is a comprehensive guide to the meter and test strips. The inratio test strips are for use with the inratio ptinr monitoring system by alerethis product has been discontinued. Alere inratio2 ptinr heparininsensitive test strips therapeutic. Aug 21, 2019 includes interfaces to the alere afinion as100, alere cholestech ldx, alere inratio 2, as well as updated product features. Alere will transition customers from the current alere. Alere to initiate voluntary withdrawal of the alere.
Alere inratio2 ptinr home monitoring system is intended for use outside of the body in vitro diagnostic use. Organization of system manual the system manual is organized into sections corresponding with the table of contents at the front of the manual. Alere inratio and inratio 2 ptinr monitoring system. Alere inratio2 ptinr monitoring system test strips. Alere lawsuit claims incorrect inratio results cause. Spectrophotometers, refractometers and benchtop instruments. If you need help accessing information in different file formats, see instructions for. Irb alere airlink for inratio user manual users guide, v. Alere lawsuit claims incorrect inratio results cause injuries.
Inverness medical inratio2 user manual pdf download. L of whole blood was shown to be required to fill the test strip and provide a test result. The inratio is easy to use, and provides accurate inr results. Alere pima cd4 absolute cd4 count in less than 20 minutes. The test specimen can be serum, plasma, fingerstick or venous whole blood. Fcc id application submitted by fitlinxx for alere airlink for inratio for fcc id o9dirb o9d irb user manual, frequency, reports, images and more. Uringlass i plast mskrukork 120ml nok 5,00 nok 6,25 infokjop. Alere hiv combo is an in vitro, visually read, qualitative lateral flow immunoassay for the simultaneous detection of free non immunocomplexed hiv1 p24 antigen ag and antibodies ab to hiv1 and hiv 2 in human blood. Alere universal printer user manual stat technologies. Dymo inratio printer manuals and user guides, printer. It appears alere has been aware of serious problems with the inratio monitor system for many years. Ptinr professional testing system user guide, and test strip.
Alere inratio 2 prothrombin timeinr monitoring system test strips test strips. The provider must have a clia certificate applicable to the complexity of the tes ting performed, and 2. Mar 02, 2017 we are no longer accepting new alere cases. If the sample receiver is spilled while opening, clean the instrument per instructions provided in the instrument user manual and cancel test. This user manual will guide you through installation, operation and maintenance of your alere afinion as100 analyzer. Alere inratio ptinr monitor test strips inratio test strips come packaged 12 test strips a box. Waived for fingerstick whole blood external quality control.
Meter, one box of coagsense test strips 03p5650 50 patient test strips, selftest user s manual, selftest quick reference guide, auto single use 21g lancets 100, ac wall adapter, 54 sample transfer tubes with plungers preloaded and carrying case. Medical device recalls alere recalls inratio and inratio2 pt. The alere inratio2 ptinr home monitoring system is not intended to be used for screening purposes. Relevant identified uses of the substance or mixture and uses advised against 1.
Waived a certificate of waiver is required to perform this test in a clia waived setting. Urgent update on the alere recalls inratio recall and inratio 2 recall. Never use a mechanically damaged ac power adaptor live connections might be exposed. The alere dds 2 mobile test system rapid screening of drugs of abuse in oral fluid digital imaging device hand held, truly portable unit test cartridge is a lateral flow immunoassay test cartridge is single use, disposable and contains dried reagents and liquid buffer lcd colour screen onscreen prompts storage of 10,000 tests print capability. Used by healthcare professionals and patients at home, the system consists of a small monitor and disposable test strips. Alere hiv combo trans continental medical products. There are no elements inside which require servicing or maintenance. As a result, you can do more than make confident, effective and meaningful decisionsyou can make a difference to your patients. Further to the information published in the below alert, more details of the recall of the alere inratio ptinr monitor system are now available alere inratio and alere inratio 2 ptinr monitors, as well as the inratio test strips that are used with these monitors, are being withdrawn from the market. Alere inratio ptinr system professional 004 alere inratio prothrombin time pt monitoring system 007 alere inratio replacement monitor 01007 alere inratio ptinr test strips 071, 01009 additional resources. Consult alere s alere inratioinratio2 brochure on medicalexpo. Ptinr monitors and inratio2 ptinr test strips collectively, the inratio.
Forbes takes privacy seriously and is committed to transparency. Take special note of cautions throughout this user guide. A strong development program results in regular releases of new versions of alere. To run a test, just add a sample to the cassette and place it into the analyzer. I have no record of receipt of this product and therefore will take no further actions. Fitlinxx alere airlink for inratio2 table of contents 1. Alr will be initiating a voluntary withdrawal of the. Field testing of the alere dds2 mobile test system for drugs in oral fluid article pdf available in journal of analytical toxicology 375 april 20 with 1,032 reads how we measure reads. Database contains 1 dymo inratio printer manuals available for free online viewing or downloading in pdf.
View and download hemosense inratio2 user manual online. A leader in rapid pointofcare diagnostics alere is now. Read this entire manual carefully, and refer to it as necessary. Det transportable system til hurtig screening og pavisning for misbrugsstoffer i spyt, kan kobes her. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed. Inratio ptinr monitoring system welcome kit includes meter, carry case, user and reference guide, ac power supply, training dvd, 50 lancets, 2 year warranty, 24 hour support and new 12 free strips. Alere dds2 mobil test system spyttest til sporing af rusmidler.
Blood tests and blood testing supplies for corporate wellness programs. The alere inratio 2 ptinr monitor connects reliable results with practical convenience, making it an optimal solution for anticoagulation management. Please note that this issue is rare and that alere inratio2 ptinr. Pt inr professional testing system user guide, and test strip. All test pieces must be removed from the instrument according to removal instructions displayed on the instrument, and disposed. It consists of a dedicated meter and individual, singleuse alere hemopoint h2 microcuvettes filled with.
Purpose and scope the purpose of this document is to describe the procedure for performing an inr test using the alere inratio2 analyser. Alr has initiated a voluntary correction to inform u. From the main menu select recall results using the keys. This means most modifications are more quickly and easily done than older source codeonly methods. Each section is controlled and maintained separately by the. Testing is allowed and reimbursed only if the provider meets the requirement s of the guidelines outlined by the clia act. The alere inratio2 ptinr home monitoring system is not intended for. Alere is urging all users of the inratio systems to find an alternative method to perform ptinr testing. The alere logo, alere and inratio are trademarks of the alere group of companies. Alere determinetm hiv12 agab combo controls are available separately and are for use only with alere determinetm hiv12 agab. San diego, california, march 2, 2017 a new lawsuit alleges the alere inratio blood monitoring system used by patients taking bloodthinners like warfarin, produces erroneous results, which can lead to serious injury or death. Alere initiates voluntary urgent product recall of alere. Alere inratio ptinr monitor system and test strips class i recall. En professional user guide inratio2 prothrombin time pt.
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