The alere inratio recall was issued by the fda because the blood clot monitoring systems were shown to deliver incorrect test results. Add to cart add to cart add to cart add to cart customer rating. Alere universal printer user manual stat technologies. Alere inratio ptinr monitoring systemplease click here to order your ptinr meter and strips today. Urgent correction issued for users of alere inratio and. 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. Alere, inratio ptinr monitor, voluntary recall, fda.
May 07, 2014 alere inratio 2 ptinr monitoring systems. Power supplies free delivery possible on eligible purchases. Alere inratio2 quick start kit inr26pk, inr2qs3, inr2qs5. Irb alere airlink for inratio user manual users guide, v. You must complete proper training on the inratio2 pt monitoring system and practice the test with a health care provider before you begin using the system.
Apr 28, 2014 alere inratio 2 ptinr professional test strips. Ppj acdc adapter for alere hemosense inratio 2 ptinr professional coaguchek meter monitor monitoring system power supply cord cable ps wall home charger mains psu. Alere inratio 2 prothrombin timeinr monitoring system test. Alere says that this issue can occur when a patient has certain medical conditions or if the instructions for performing the test are not followed. Alere inratio 2 ptinr monitor w case and accessories pn 28184, read descr.
Alere connectivity pack i samba3ge falcom wireless communications gmbh gewerbering 6 d98704 langewiesen, germany for more information, original user manual and technical description of samba3ge please. The meter displays test results and menu options in the upper half of the meter screen. Alere inratio and inratio 2 ptinr monitoring system. The user manual also explains how the analyzer works, describes the quality assurance system and assists you in troubleshooting. By now, the allegations against alere over its inratio and inratio 2ptinr monitor system and inratio test strips are well known to the legal community and patients who have used these devices. Fda medwatch inratio and inratio2 ptinr monitor system. Alere inratio2 ptinr heparininsensitive test strips. Alere recalls inratio and inratio2 ptinr monitoring system. A system for measurement of ppt inr manufactured by. Alere inratio 2 prothrombin timeinr monitoring system test strips for use with inratio 2 ptinr monitor systems. Alere inratio ptinr monitor system therapeutic goods. It appears alere has been aware of serious problems with the inratio monitor system for many years. Alr will be initiating a voluntary withdrawal of the alere inratio and inratio 2 ptinr monitoring system. Ahiinr24pk inratio2 pt inr monitor and 4 boxes of inratio test strips ahiinr26pkinratio2 pt inr monitor and 6 boxes of inratio test strips ahiinr2qs1 inratio 2,1 box inratio test strips, 50 unistik single use lancets, 100 alcohol pads, brick of gauze,150 capillary sampling tube.
Jul 12, 2016 the alere inratio and alere inratio2 are portable monitoring systems that can be used by doctors and patients for anticoagulation management. Purpose and scope the purpose of this document is to describe the procedure for performing an inr test using the alere inratio2 analyser. Food and drug administration and state and local regulatory agencies. In addition to the application, the fcc also publishes internal images, external images, user manuals, and test results for wireless devices. Alere inratio professional users guide 0200123 from 4md. The company is uncertain as to why the strips are failing to give an accurate reading. Alere starts voluntary correction about use of alere. Aleres recalled inratio monitor system promised easy and. In a few minutes the results will appear on the screen. The purpose of this study was to determine the reliability of the pst device alere inratio 2 in patients supported with cflvads. The following symbols and abbreviations are used in the product labelling and instructions for the alere afinion 2 system. Qty 1 users guide qty 1 quick reference guide qty 1 carrying tote. Connect other end of the communication cable to the testing device. Is performing ptinr selftesting with the inratio2 really as easy as 1 2 3.
Alere cholestech ldx system user manual pdf download. Our services ensure patients become successful longterm home testers including face 2 face training, patient support services and education, compliance program with patient reminders, service protocols. The alere inratio 2 ptinr professional monitoring system is intended for use outside of the body in vitro diagnostic use. Once the setup is complete, users are ready to utilize their alere inratio to perform selftesting. Have you been injured using the alere inratio blood clot monitoring system. Alere cholestech ldx quick reference manual pdf download. Our unique id now isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. Because the inr level is critical to a patients health, the inratio s accuracy and precision is of vital important to a patients wellbeing. Accessible molecular testing in 52 minutes accessible take molecular hiv testing where its needed most save time, save. The recall for alere inratio and inratio2 by the food and drug administration has been upgraded to a class i recall, meaning use of the product could cause serious or adverse health consequences and even death. The alere afinion as100 analyzer makes it easy to do accurate assays right in your office for onthespot results, faster diagnoses and wellinformed treatment decisions. Never use a mechanically damaged ac power adaptor live connections might be exposed. Alere inratio ptinr monitor systems comprise an inratio or inratio 2 monitor and inratio or inratio 2 test strips. Alere san diego is initiating a voluntary recall for the alere inratio.
Ptinr professional testing system user guide, and test strip. Individually foilwrapped test strips can be stored at room temperature for up to 12 months. Urgent product recall for patients on blood thinners. Alere inratio 2 prothrombin timeinr monitoring system. If you need help accessing information in different file formats, see instructions for downloading viewers and players. Inratio class action lawsuit inratio recall lawsuits.
The monitor system was for professional and prescription home use. Alere to initiate voluntary withdrawal of the alere inratio. Alere inratio replacement monitor 01007 alere inratio ptinr test strips 071, 01009 2014 recalls. Using one of these devices could ultimately prove to be fatal, if not at the very least exceptionally injurious. It provides an accurate and convenient measurement of blood clotting time, or ptinr. Alere inratioinratio2 pdf catalogs technical documentation. Alere inratio 2 ptinr home monitoring hemosense inratio2 for. 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. The federal drug administration has initiated a recall on alere inratio and inratio 2pt inr monitoring systems. Press stop at any time to exit the configuration menu.
The inratio 2 pt monitor comes with a power supply but you must plug it into the inratio2 and a wall jack before the monitor will turn on. The alere inratio 2 ptinr home monitoring system, consisting of the inratio 2 home monitor and inratio ptinr test strip, is used for quantitative. April 16, 2014 alere recalled its inratio2 ptinr professional test strips pn 99008g2. Alere inratio error codes the monitor automatically performs electronic selftests for battery condition, proper heating range, temperature and memory on each test, assuring the user that the device is. Alere will work with you to customize an approach for implementing the home inr monitoring program to meet the needs of your practice. Patients must be stabilized 6 weeks on warfarin therapy. Mar 02, 2017 we are no longer accepting new alere cases. The inratio monitor is a handheld device that measures bloodclotting times by reading test strips. Alere inratio and inratio 2 ptinr monitoring systems. Alere inratio2 method and sample collection method ie. The id now instrument is factory calibrated and does not require any. The sale of this item may be subject to regulation by the u. A copy of the press release is attached to this current report on form 8k as exhibit 99.
Page 17 when english is the selected language, am or pm is displayed. While inserting the connectors plugs into the inratio2 meter make sure they go in evenly at the same time. About this user manual this user manual will guide you through installation, operation and maintenance of your alere afinion as100 analyzer. Under no circumstances should you open the ac power adaptor. Coagulation test strip inratio mckesson medicalsurgical. Alere q hiv 12 detect provides access to testing and critical results in time to get children on treatment during the 812 week window of opportunity. Alere starts voluntary correction about use of alere inratio. Press and hold the button until the monitor turns on.
Alere will transition customers from the current alere inratio2 ptinr professional test strip to the alere inratio ptinr test strip pn 1009. Use of shorten dapt and the xience stent in highbleeding risk patients. Alere manufactured and distributed the system between april 1, 2008 and december 4, 2014. Get molecular, virological results at the point of care, in 52 minutes, while mother and child are still present.
Rigorous integrated quality control checks are performed automatically with every test strip, ensuring a reliable result. Class 1 device recall alere inratio inratio2 ptinr test strips. Class i recall of alere inratio and inratio2 ptinr monitoring system due to inr result that is lower than the result expected. This recall is of the class i variety, which is the most serious type there is. Open the drawer perform a fingerstick collect the sample dispense the sample connecting the alere configuration menu cholestech ldx analyzer. This action is being initiated as a result of patients who had a therapeutic or neartherapeutic inr with the alere inratio.
Class 1 device recall alere inratio inratio2 ptinr test. Alere inratio 2 ptinr monitor w case and accessories pn. In december 2014, alere initiated a voluntary correction to inform users of the inratio and inratio2 ptinr monitoring system that patients with certain medical conditions should not be tested with the system. The alere inratio lawsuit concerns the use of the alere inratio and inratio 2pt inr. It consists of a dedicated meter and individual, singleuse alere hemopoint h2 microcuvettes filled with. You and your office also save time and money by improving workflow and reducing patient followup visits. The alere inratio monitor system and test strips are used by patients to monitor their inr levels while on warfarin. Insert a fresh test strip if you are ready to perform a test. Alere inratio2 ptinr testing kit new meena medical equipment. Alere initiates voluntary urgent correction for use of alere. Alere inratio2 quick start kit inr26pk, inr2qs3, inr2.
Take special note of cautions throughout this user guide. While holding the feed button, turn on the power switch. Jackie lustig 78414009 manufacturer reason for recall. Alere inratio recall legal news and lawsuit information. Insert the lithium coin battery into the battery well, and then slide the battery cover in.
In december 2014, alere issued a recall of its inratio and inratio2 ptinr monitor systems after receiving almost 19,000 complaints, including three deaths. This item has been discontinued by the manufacturer and is no longer available. Consult alere s alere inratio inratio 2 brochure on medicalexpo. Urgent correction issued for users of alere inratio and inratio2 ptinr monitor system the makers of the inrratio and inratio 2 ptinr monitor system have initiated an urgent correction to inform users of these devices in the u. The alere inratioinratio2 ptinr monitoring system is intended for professional and home use by people taking warfarin and other oral. While alere advertises the inratio as a simple three step process, there are several other intermediary actions which. A correlation study was performed in 50 patients with cflvad who were on stable warfarin therapy for a minimum. On december 5, 2014, alere issued a second recall, this time regarding its inratio and inratio 2 ptinr monitor system. Turning the monitor on you have 2 options for turning the monitor on.
Alere initiating voluntary recall of inratio and inratio2 ptinr. Fitlinxx alere airlink for inratio irb fcc id o9dirb. When any other language setting is selected, the hours are shown in 24hour format from 00. If an incorrect low inr result is acted upon the patient may be at. There are no elements inside which require servicing or maintenance. Dispose of all alere inratio inratio 2 ptinr monitors in your possession in compliance with the instructions set forth in the enclosed reply form option a or return all alere inratio inratio 2 ptinr monitors in your possession to alere san diego, inc. Alere connectivity pack i and ii alere pdf catalogs. En professional user guide inratio2 prothrombin time pt. If you are a current user of the alere inratio inratio 2 ptinr monitoring. It is easy to use and gives fast and reliable results. Inratio 2 ptinr assistance or additional information. This is confirmed in the bland altman graph shown in figure 1 below. Jul 11, 2016 alere san diego is initiating a voluntary recall for the alere inratio. This is a class 1 recall, the most serious classification issued by the fda for medical device pro.
While inserting the connectors plugs into the inratio2 meter make sure they go. Class 1 device recall inratio2 ptinr home monitoring system. Ensure the green led is off and the printer is powered off. One unmeasured drop of blood applied directly to the strip performs both the test and quality controls. In addition to the recent action, alere has issued at least 2 other recalls for its inratio monitoring system and test strips. Page 2 setup test procedure take the time to examine and familiarize yourself with the contents of the alere cholestech ldx system. Yet another recall has been made on the heels of serious and traumatic device malfunctions nearly 19,000 reports, to be exact. Hemosense inratio2 user manual pdf download manualslib. Alere inratioinratio2 alere pdf catalogs technical. The recall in 2014 came because the alere inratio and. Irb alere airlink for inratio user manual users guide, v 1. To run a test, just add a sample to the cassette and place it into the analyzer. Correlation between home inr and core laboratory inr in pati.
Consult alere s alere inratioinratio2 brochure on medicalexpo. The alere inratio2 ptinr professional monitoring system, consisting of the alere inratio2 ptinr monitor and the alere inratio2 ptinr professional test strip, is used for quantitative determination of international normalized ratio inr in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. Insert the data cable to the suitable interface on the back of the printer, and fixed it with a screw or clip spring. Ensure the printers power source is connected and the paper roll with spool is loaded into the paper housing. Recall on alere inratio2ptinr monitoring system vessel. Buy acdc adapter for alere hemosense inratio 2 ptinr professional coaguchek meter monitor monitoring system power supply cord cable ps wall home charger mains psu. Pt inr professional testing system user guide, and test strip. The lower slope value with inratio2 suggests that it is biased higher when compared to the coagsense system.
May 01, 2017 according to court documents, alere had issued a memorandum to users of the inratio device in december, 2014 suggesting the inratio system should be avoided by patients with specific medical. They are used by health professionals and for selftesting by patients who are taking anticoagulant medicines, sometimes referred to as bloodthinners, such as warfarin. Fda recalls alere inratio and inratio2 monitor systems. Alere inratio2 ptinr professional monitoring system. Urgent correction issued for users of alere inratio and inratio2. Those patients are ones treated with the anticoagulant drug warfarin or coumadin.
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