ACCURUN 1 MULTI-MARKER POSITIVE CONTROL

Additional Manufacturer Narrative

SINCE THE PRODUCT WAS TRANSFERRED FROM ITS ORIGINAL CONTAINER BY THE LAB, NO REQUEST WAS MADE FOR RETURN OF THE PRODUCT. THE PRODUCT IS SUPPLIED BY THE MFR IN A VIAL WITH A SCREW CAP CLOSURE. THE LAB ROUTINELY ALIQUOTS THE PRODUCT FROM ITS ORIGINAL CONTAINER TO A BULLET TOP TUBE WITH A SNAP TOP CLOSURE. THE PRODUCT LABELING INCLUDES A SAFETY PRECAUTION STATEMENT TO USE UNIVERSAL PRECAUTIONS WHEN HANDLING THE PRODUCT.

Description of Event or Problem

TECHNOLOGIST REPORTED EYE SPLASH WITH PRODUCT. SHE EXPERIENCED DIFFICULTY SNAPPING OPEN THE BULLET TOP TUBE (THE PRODUCT IS MANUFACTURED AND SHIPPED IN A SCREW TOPPED CONTAINER, BUT THE LABORATORY ALIQUOTS THE PRODUCT OUT OF THIS ORIGINAL CONTAINER INTO BULLET TOP TUBES). WHEN SHE APPLIED FORCE TO SNAP OPEN THE CAP, UPON OPENING, DROPLETS OF THE PRODUCT SPLASHED INTO HER RIGHT EYE. TECHNOLOGIST WAS NOT WEARING PROTECTIVE EYEWEAR. SHE FLUSHED HER EYE WITH WATER FROM THE LABORATORY EYEWASH STATION. TECHNOLOGIST SOUGHT MEDICAL EVALUATION, AS THE PRODUCT CONTAINS CHEMICALLY TREATED HIV AND HEPATITIS POSITIVE RAW MATERIALS. AS A PRECAUTION, THE TECHNOLOGIST RECEIVED ANTI-HIV PROPHYLAXIS. NO HEPATITIS VACCINE WAS ADMINISTERED AS SHE HAD ALREADY BEEN IMMUNIZED AGAINST HEPATITIS B.