Duplicate testing no longer needed for CoaguChek strips.Roche Diagnostics, in cooperation with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , announced May 23 that the Urgent Medical Device Correction issued for CoaguChek PT test strips (UMDC UMDC Universal Medical Device Code 06 266), used in anticoagulation monitoring, has been addressed and duplicate testing duplicate testing Lab medicine The inappropriate repeating of lab or other diagnostic evaluations–eg, CBC, U/A, CK-MB, BMP, more often than allowed by Medicare or third party payers is no longer required for CoaguChek PT Test Strips, lot numbers 560A and higher (e.g., 561A, 562A, ...). The potential for erroneous prothrombin time (PT) test results that prompted the UMDC was a result of insufficient active ingredient (thromboplastin thromboplastin: see blood clotting. ) on selected test strips. Fully tested and validated changes have been implemented within the manufacturing process to address this concern. Every test strip is inspected to ensure that it contains the correct amount of thromboplastin before being packaged and shipped. All healthcare professionals performing duplicate testing to confirm results can return to a single test using CoaguChek PT Test Strips (only from lot numbers 560A and higher) to monitor patients on warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. (anticoagulation) therapy. All patients previously performing patient self-testing may now resume monitoring with CoaguChek PT Test Strips (only from lot numbers 560A and higher). |
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