February 1, 2019 / 8:37 PM / 16 days ago

BRIEF-FDA Warns Patients And Doctors About Recall Of Home-Use Test Strips

Feb 1 (Reuters) - U.S. Food and Drug Administration:

* FDA WARNS PATIENTS & DOCTORS ABOUT RECALL OF HOME-USE TEST STRIPS USED WITH DEVICE TO MONITOR BLOOD THINNER WARFARIN, NOT AUTHORIZED FOR SALE IN U.S.

* FDA- CLASSIFIED TERRIFIC CARE/MEDEX SUPPLY VOLUNTARY RECALL AS CLASS I RECALL WHICH MEANS USE OF THESE DEVICES MAY CAUSE SERIOUS INJURIES OR DEATH

* FDA SAYS COAGUCHEK XS PT TEST STRIPS RECALL WERE MANUFACTURED BY ROCHE, BUT DISTRIBUTED BY TERRIFIC CARE/MEDEX SUPPLY

* FDA - RECALL IS RELATED TO NOVEMBER 2018 ROCHE DIAGNOSTICS RECALL, THE MANUFACTURER OF COAGUCHEK METERS AND TEST STRIPS

* FDA - TODAY’S RECALL INCLUDE CATALOG NUMBERS THAT WERE NOT INCLUDED IN RECENT ROCHE RECALL AS STRIPS WERE NOT LABELED OR AUTHORIZED FOR SALE IN U.S. Source text for Eikon: Further company coverage:

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