COMBUR-9-TEST

Additional Manufacturer Narrative

ONE VIAL OF COMBUR-9-TEST 100 STR. OF LOT# 40392902 CONTAINING 124 OF 100 TEST STRIPS WAS RECEIVED FOR INVESTIGATION. 79 OF THE TEST STRIPS WERE DISCOLORED AND 45 TEST STRIPS SHOWED NO ABNORMALITIES AS THERE WERE MORE STRIPS IN THE VIAL THAN WHEN MANUFACTURED AND THE CUSTOMER MIXED UP SEVERAL STRIP LOTS TOGETHER IN ONE VIAL, THE ISSUE WAS DETERMINED TO BE A HANDLING ERROR BY THE CUSTOMER. PRODUCT LABELING FOR THE PRODUCT STATES " TIGHTLY RE-CAP THE CONTAINER IMMEDIATELY AFTER REMOVING A TEST STRIP. THIS WILL AVOID DISCOLORATION OF THE STRIPS."

Additional Manufacturer Narrative

THE CUSTOMER¿S PRODUCTS HAVE BEEN REQUESTED FOR RETURN. THE RETENTION MATERIAL OF LOT 40392900 WAS VISUALLY CHECKED. THE RETENTION MATERIAL SHOWED NO ABNORMALITIES AND NO SIGNS OF DISCOLORATIONS. THE RETENTION MATERIAL FULFILLED THE REQUIREMENTS. THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULT FALSE POSITIVE NITRITE RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER HAD NOTICED ALMOST HALF OF THE TEST STRIPS IN THE VIAL HAD A DISCOLORED NITRITE PAD THAT WAS LIGHT PINK BEFORE THE TEST STRIP WAS USED. THEY BELIEVED THIS LED TO THE FALSE POSITIVE NITRITE RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.