LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT

Description of Event or Problem

A LAB PROFESSIONAL SPLASHED CONTROL MATERIAL IN HER EYE. SHE WAS TRYING TO REMOVE BUBBLES FROM AN INSTRUMENT CUVETTE WHEN THE PIPETTE TIP 'CAUGHT' AND FLICKED THE CONTROL MATERIAL IN HER EYE. THERE WAS NO IMMEDIATE HARM TO THE LAB PROFESSIONAL.

Additional Manufacturer Narrative

THE LABELING AND CERTIFICATE OF ANALYSIS OF THE CONTROL MATERIAL INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS TESTED BY FDA-ACCEPTED METHODS AND FOUND NON-REACTIVE FOR (B)(6). IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PT SPECIMENS. ROOT CAUSE OF EVENT: USER ERROR.