PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES

Additional Manufacturer Narrative

THE FOLLOWING NARRATIVE IS CONTAINED IN THE PRODUCT PACKAGE INSERT: "THE PROBECHEK CONTROLS AND ALL OTHER FRESH OR FIXED SPECIMENS SHOULD BE HANDLED AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS. DISPOSE OF WITH PROPER PRECAUTIONS. BECAUSE IT IS OFTEN IMPOSSIBLE TO KNOW WHICH MIGHT BE INFECTIOUS, ALL SPECIMENS ARE TO BE TREATED WITH UNIVERSAL PRECAUTIONS. GUIDELINES FOR SPECIMEN HANDLING ARE AVAILABLE FROM THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION. MATERIAL SAFETY DATA SHEETS (MSDS) ON ALL MATERIALS SUPPLIED IN THE PROBECHEK CONTROLS ARE AVAILABLE FROM THE ABBOTT MOLECULAR TECHNICAL SERVICE DEPARTMENT. AVOID CONTACT OF PROBECHEK SLIDES WITH SKIN AND MUCOUS MEMBRANES."

Description of Event or Problem

THE PROBECHEK UROVYSION CONTROL SLIDES ARE NON-HYBRIDIZED SLIDES PREPARED WITH CULTURED NORMAL MALE LYMPHOBLAST CELLS AND CULTURED BLADDER CANCER CELL LINES. EACH CONTROL SLIDE CONSISTS OF TWO SEPARATE TARGET AREAS IN WHICH EACH OF THE DIFFERENT CELL TYPES HAVE BEEN APPLIED. THE CELL LINES ARE HARVESTED, FIXED IN SUSPENSION MEDIUM, AND APPLIED TO THE GLASS MICROSCOPE SLIDES IN A METHOD OPTIMAL FOR FISH (FLUORESCENCE IN SITU HYBRIDIZATION). A CUSTOMER REPORTED THAT ONE OF THE THREE SLIDES IN A PROBECHEK UROVYSION BLADDER KIT CONTROL SLIDES PACKAGE WAS BROKEN. THERE WAS NO DAMAGE TO THE EXTERIOR SHIPPING BOX. THERE WERE NO INJURIES REPORTED. THE BROKEN SLIDE WAS DISPOSED OF IN A SAFE MANNER.