Due to the possible inaccurate low INR results, Alere has advised customers to immediately stop using the Alere INRatio2 PT/INR Professional Test Strips. Alternate methods of PT/INR testing, such ...

The recall covers the following CoaguChek XS PT Test models distributed between January 12 and October 29 of this year: 2x24 strips, 6 strips, and 24 tests USA. The FDA said users of the recalled ...

A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings. Roche Diagnostics ...

Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US.

Cite this: FDA: Class I Recall of Roche Warfarin Test Strips for INR Monitoring - Medscape - Nov 01, 2018. Authors and Disclosures. Authors and Disclosures Journalist Steve Stiles.

Interface Data Systems expands their capabilities by working in conjunction with Hemosense, a medical device manufacturer, to develop a test strip for its INRatio meter. The INRation meter is a ...

The test strip results were between 3.1-12.2 INR units lower than the lab result, the company said in a May 7 statement, and it is concerned that the test strips may be inaccurate and ...

The recalls follow reports that the test strips may indicate an international normalized ratio (INR) that is higher than the actual INR, which could lead to prescription of warfarin doses that are ...

The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

In November 2018, Roche Diagnostics issued a recall of more than 1.1 million packages of CoaguChek XS PT Test Strips. Subsequently, medical product distributor, Terrific Care/Medex Supply LLC ...