COULTER® 4C® PLUS CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEIR COULTER 4C PLUS CELL CONTROL VIAL WAS BROKEN AND LEAKED. THE LEAK WAS DISCOVERED AFTER THE BOX CONTAINING THE VIAL WAS REMOVED FROM THE REFRIGERATOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO REPORTS OF EXPOSURE TO EYES OR SKIN, MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH OR SERIOUS INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

Additional Manufacturer Narrative

SERVICE WAS NOT DISPATCHED. A COURTESY REPLACEMENT WAS SENT TO THE CUSTOMER. AT THIS TIME, THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. PER MSDS LABELING: THIS PRODUCT SHOULD BE HANDLED AS THOUGH CAPABLE OF TRANSMITTING INFECTIOUS DISEASE. UNIVERSAL PRECAUTIONS SHOULD BE FOLLOWED WHEN USING THIS PRODUCT.