Where To Buy Coaguchek Xs Pt Test Strips VERIFIED
The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. Today, the FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.
where to buy coaguchek xs pt test strips
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Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, with atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.
INR self-testing with the CoaguChek portable coagulation monitoring system provides patients with freedom, allowing them to test virtually anywhere at any time, without having to visit a healthcare provider.
This system is easy and convenient to use as the strips allow for dosing from the top, right, or left for simpler blood application. The dosing size is very small, at only 8µl, and the CoaguChek system uses the fingerstick test. Most patients prefer this method because it ensures that they will have the most comfortable testing experience possible with a non-invasive finger test.
Your team will love using CoaguChek test strips. The results are accurate and precise, and load within approximately one minute. The system also performs on board quality control, so no outside QC is needed. These test strips, sold in 48 test boxes, can be used to manage a large variety of patients with only one simple, accessible device. The device is small, battery powered, and easy to use in even the most chaotic environments. The automatic controls turn the device on with strip insertion and off with time, so you do not have to worry about a thing. Your testing process will be simplified for you and your patients with the CoaguChek XS System and test strips.
Terrific Care, LLC. / Medex Supply is recalling the Roche Diagnostics CoaguChek XS PT Test Strips due to inaccurate INR test results when compared to laboratory results. The test strips may provide results that are higher than the actual INR. Because of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at an elevated risk of stroke, or those who had a recent blood clot.
Roche Diagnostics CoaguChek XS PT Test Strips are a flexible, accurate test strips used for PT/INR anticoagulation testing
1 Chip per box
CLIA Waived
Item Id 1172455 MF ID 04625315160 Brand CoaguChek XS PT Test Manufacturer Roche Diagnostics Application Coagulation Test Strip Contents 2 Vials X 24 Strips For Use With For CoaguChek XS Meter Product Dating McKesson Acceptable Dating: we will ship >= 60 days Reading Type Machine Read Storage Requirements USP Controlled Room Temperature Test Type PT / INR UNSPSC Code 41115810
Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to the most recent International Normalized Ratio (INR) Standard. Since calibrating to this new standard, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected lots of CoaguChek XS PT Test Strips listed in the table below.
The affected test strips in the table above will be replaced with new CoaguChek XS PT Test Strips, which are not impacted by the Urgent Medical Device Correction (UMDC) and can be used without the need for confirmatory measurements with a laboratory method.
The Roche CoaguChek XS PT Test is a blood-testing device used to measure the clotting ability of blood. The device utilizes a small disposable test strip, which is inserted into the device and used to draw a small amount of blood. The blood is then analyzed for its clotting ability, and the results are displayed on the device's LCD screen. The Roche CoaguChek XS PT Test can be used to measure the clotting ability of both blood and plasma, and can be used to test a variety of different clotting times. Roche CoaguChek XS PT Test Strips are a flexible, accurate test strips used for PT/INR anticoagulation testing.
When you are taking warfarin or when you have unexplained or prolonged bleeding or inappropriate blood clotting, it is a good idea to test prothrombin time (PT) and the international normalized ratio (INR). PT/INR testing is done to determine the clotting tendency of blood. CoaguChek XS PT Test Strips allows users of anticoagulation medications or blood thinners such as Coumadin and warfarin to monitor and determine the coagulation of blood in the privacy of their own home. Now you can get fast and accurate results without long drives or expensive visits to the clinic. Roche Diagnostics developed the CoaguChek XS System for home and point of care monitoring as an alternate to lab based methods with remarkable accuracy. Only 10 microliters of blood will be able to provide you with results within approximately 20 seconds to one minute. Ideal for beginners, the CoaguChek XS PT Test Strips allows blood sample to be applied to any side of the strip for convenience. Each box contains a code chip for test strip coding. CoaguChek XS PT test strips are for use with the CoaguChek XS Home Patient System. Although the CoaguChek XS System was designed for home use, it is also trusted by healthcare professionals for on-the-spot analysis of coagulation levels during mobile emergency treatment, in hospital and in general practice. Trust Roches coagulation monitoring systems for smart, accurate technology.
Results: From May 1 to September 11, 2018, 16 of 166 patients were affected by recalibrated strips, resulting in 19 of 1176 INRs being greater than 4.5. Almost half (47%) of elevations were due to unknown causes, and most were corrected by holding at least 1 dose. Of the 152 patients treated from September 12 to November 2, 8 patients were affected by the recalibration, resulting in 11 of 453 INRs being greater than 4.5. Six resulted in confirmatory INR testing with an average difference of 2 points. No bleeding events or hospitalizations were reported in either group.
Roche Diagnostics has recalled 43 lots of CoaguChek XS PT test strips to the patient level (Class I recall). The affected strips have a recalibration defect that affects the accuracy of the results. Since Roche recalibrated the CoaguChek XS PT test strips to the new International Normalized Ratio (INR) standard in January 2018, they have received reports of abnormally high and inaccurate INR test results. The affected products were distributed between January 12 and October 29, 2018, and are used with the following meter devices:
Customers should stop using and discard the affected test strips, and should not rely on the affected test strips to monitor their INR. Patients with the affected test strips should contact their healthcare provider and have their INR measured by a laboratory test or an alternate meter. Healthcare providers and patients can call Roche Diagnostics 1-800-428-4674 for additional details about this recall.
Coaguchek XS PST Strips for INR TestingCoaguchek Test Strips for the Coaguchek XS INR Device for INR testingCoaguChek XS PT Test PST strips are use with the CoaguChek INRange device, for personal INR testingCoaguChek XS PT Test PST provide a precise determination of the prothrombin time within only a few secondsNote:These strips will also work in the previous device machine- The CoaguChek XS INR Meter DeviceRelated ProductCoaguChek INRange System Devic
The strips require a minute blood sample and the strips allow dosing from either side for quick and simple application process. Results are ready in approximately one minute. A code chip is included in every box of CoaguChek XS PT/INR test strips.
Usage of the CoaguChek XS PT/INR test strips with the PT/INR machine greatly reduces the number of doctor visits, and helps patients regain control over their condition. For a demonstration on how to properly apply blood to the INR test strip CLICK HERE. 041b061a72