HYPOGUARD

Description of Event or Problem

FALSE POSITIVE LEUKOCYTES, NITRITES AND BILIRUBIN ON HYPOGUARD DIASCREEN (50) URINE DIPSTICK READER/HYPOGUARD REAGENT STRIPS. COMPANY HAS RESOLVED NITRITE PROBLEM AND HAS FINALLY ADMITTED TO LEUKOCYTE FALSE POSITIVES AND HAS COME OUT WITH NEW AND IMPROVED LEUKOCYTE REAGENT STRIPS BUT WILL NOT TAKE BAD STRIPS OFF THE MARKET BY RECALLING THEM, EVEN THOUGH THEY HAVE PROVEN THEY ARE DEFECTIVE. AFTER MUCH EFFORT, ON RPTR'S PART. REPORTER CANNOT GET COMPANY TO DO ANYTHING ABOUT FALSE POSITIVE BILIRUBINS. THEY CALLED REPORTER 12/03 AND SAID THEY COULD NOT DO ANYTHING MORE EVEN THOUGH REPORTER PROVED TO THEM REPORTER IS GETTING 8-9% FALSE POSITIVES AND THEY ARE SAYING REPORTER SHOULD ONLY HAVE 1-4% FALSE POSITIVE. REPORTER FEELS THESE STRIPS SHOULD BE IMPROVED OR BE REMOVED FROM MARKET.