MAR DX TRINITY BIOTECH MARDX EU LYME + VLSE IGG WESTERN BLOT,

Description of Event or Problem

CRITICAL MEDICAL INCIDENTS OCCURRED INCLUDING INJURIES DUE TO FAULTY MEDICAL DEVICES MAR DX TRINITY BIOTECH WB CLASS II TGA, TWO-TIER LYME DISEASE SEROLOGY NATA ACCREDITED AND RCPA VALIDATED TESTING APPROACH FAILED: PATIENT COMPLAINT WITH SCIENTIFIC EVIDENCE. PATIENT PERFORMED PROCESS VALIDATION ON A REAL BLOOD SPECIMEN OF FEW NATA ACCREDITED HIGH VOLUME LABORATORY FACILITIES WHICH PRODUCED FALSE NEGATIVE DISCORDANT RESULTS, LED TO LATE-STAGE NEUROLOGICAL LYME DISEASE AND 5 YEARS DELAY OF IV ANTIBIOTIC TREATMENT. FALSE NEGATIVE DISCORDANT RESULT GENERATED. LATE-STAGE NEUROLOGICAL LYME DISEASE AS AN OUTCOME FROM A FAULTY MEDICAL DEVICE.