PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL

Description of Event or Problem

A CUSTOMER REPORTED THAT PROBECHEK PATHVYSION CONTROL SLIDES THAT WERE SHIPPED WERE BROKEN UPON ARRIVAL. THE PLASTIC CASE HOUSING THE PROBECHEK PATHVYSION CONTROL SLIDES HAD POPPED OPEN. THE CUSTOMER STATED TWO PROBLEMS WITH THE BOX'S CONTENTS: HEAVY REAGENTS WERE ON TOP OF THE PROBECHEK SLIDES, NO CUSHION WRAP WAS USED AROUND THE SLIDES DURING SHIPMENT. THE SLIDES WERE BROKEN. CUSTOMER STATED THAT A PERSON COULD HAVE CUT THEMSELVES DUE TO THE GLASS SHARDS. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

ABBOTT MOLECULAR AT THIS TIME BELIEVES THAT THIS INCIDENT IS A PACKAGING ERROR - I.E., THE CUSTOMER REPORTED THAT NO PACKAGING MATERIAL WAS USED TO WRAP THE BOX OF THE PROBECHEK SLIDES FOR THE PATHVYSION HER-2/NEU ASSAY. THE REVIEW OF THE OPERATING PROCEDURES FOR THE PACKAGING OF THE SLIDES WAS COMPLETED AND DETERMINED THAT ONLY COLD STORAGE BOXES OF SLIDES ARE CUSHIONED WRAPPED, BUT NOT FOR AMBIENT SHIPMENT.