BREATHTEK UBT COLLECTION KIT

Description of Event or Problem

A FEW MINUTES AFTER THE PT DRANK THE PRANACTIN CITRIC DRUG SOLUTION AS PART OF THE BREATHTEK UBT H. PYLORI TEST, SHE REPORTED DISCOMFORT AND NUMBNESS IN LIMBS, SHE WAS FLUSHED AND WAS HAVING HEART PALPITATIONS, AND WAS FEELING ANXIOUS, THE BACK OF HER FELT HOT AND COLD OVERALL.

Additional Manufacturer Narrative

MANUFACTURING BACKGROUND INFO. MERETEK CONTRACTS OUT THE MANUFACTURE OF THE BREATHTEK UBT COLLECTION KIT, WHICH OCCURS IN THREE SEPARATE PHASES: PHASE 1 - MANUFACTURE OF THE BULK GRANULATED PRANACTIN -CITRIC DRUG COMPONENT. THIS PART OF THE MANUFACTURE IS PERFORMED BY VPS CORPORATION. PHASE II - PACKAGING THE BULK PRANACTIN CITRIC DRUG COMPONENT INTO POUCHES. THIS PART OF THE MANUFACTURE IS PERFORMED BY CARDINAL HEALTH. PHASE III - ASSEMBLY OF THE KIT COMPONENTS INTO THE BREATHTEK UBT COLLECTION KIT. THIS ASSEMBLY IS PERFORMED BY HERITAGE LABS INTERNATIONAL, LLC. THE FINISHED BREATHTEK UBT COLLECTION KITS ARE DISTRIBUTED BY (B)(4) TO MERETEK DIAGNOSTICS, INC. CLIENTS.