WebOur records indicate that you have received at least one Alere INRatio® ®or Alere INRatio 2 PT/INR MonitoringSystem manufactured by Alere San Diego, Inc. Details on affected devices: The following devices/part numbers are affected: Alere INRatio® PT/INR System Professional 0100004 Monitor Alere INRatio® Prothrombin Time PT Monitoring System ... WebOnly use the Alere INRatio2 PT/INR heparin-insensitive test strips on patient samples within the labelled haematocrit range of 25% to 53%. Patient samples with a haematocrit below the labelled range, which also have a high INR, may result in a discrepant low INR with the Alere INRatio2 PT/INRP Monitoring System.
Alere INRatio PT/INR monitor system - Therapeutic Goods …
WebSeller Notes. “Alere InRatio 2 PT/INR Monitor. Power supply included is not the one that comes with the unit. It is same Voltage 7.5, slightly lower Amperage 1 Amp as opposed to 1.3.... No accessories included, Monitor only, it's the one with the silver control pad, not the orange one. Powers up and seems to be O.K. WebThe INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. lake park ga us
ALERE 28184 Patient Tester Coagucheck Monitor Handheld Meter
WebJul 11, 2016 · This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. FDA Determined Cause 2: Other: Action: Alere issued a press release on … WebMay 7, 2014 · Alere has issued an urgent, voluntary recall of their INRatio®2 PT/INR Professional Test Strips (PN 99008G2). Readers whose loved ones are taking warfarin … WebThe purpose of this study was to determine the reliability of the PST device Alere INRatio 2 in patients supported with CF-LVADs. A correlation study was performed in 50 patients with CF-LVAD who were on stable warfarin therapy for a minimum of 3 weeks. Simultaneous INR values were determined from capillary whole blood samples using the Alere ... jenise martinez