COULTER® 4C® PLUS CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEIR COULTER 4C PLUS CONTROL VIAL WAS FOUND CRACKED. CONTROLS WERE NOT LEAKING WHEN REMOVED FROM THE REFRIGERATOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO REPORTS OF EXPOSURE TO OR CONTACT WITH 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.