PROBECHEK UROVYSION CONTROL SLIDES

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). CUSTOMER OPENED BOX AND SAW THAT TWO SLIDES WERE BROKEN. CUSTOMER STATED THAT SHE RECEIVED PACKAGE WITH NO OBVIOUS DAMAGE TO CARTON; UPON OPENING UROVYSION CONTROL SLIDES, CUSTOMER SAW THAT TWO OUT OF THE THREE SLIDES WERE BROKEN. CUSTOMER IMMEDIATELY CLOSED THE BOX. THERE WAS NO INJURY. PER PROBECHEK CONTROL SLIDES FOR FLUORESCENCE IN SITU HYBRIDIZATION (FISH) USING UROVYSION BLADDER CANCER KIT PACKAGE INSERT ((B)(4)): "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."

Additional Manufacturer Narrative

ABBOTT MOLECULAR IS CURRENTLY INVESTIGATING THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.