API® NH TEST STRIP

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING A REPORT OF DISCREPANT RESULTS ASSOCIATED WITH API® NH (REFERENCE 10400). THE CUSTOMER STATED THE EXPECTED IDENTIFICATION AS NEISSERIA SICCA; HOWEVER, THE RESULT OBTAINED WAS NEISSERIA GONORRHEA 98% (GOOD ID). REPEAT TESTING CONFIRMED THE MISIDENTIFICATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. DUE TO THE EXPIRATION (28SEP2017) OF THE INCRIMINATED BATCH (LOT 1005423530), TESTING WAS NOT POSSIBLE; HOWEVER, THE STRAIN, ATCC 9913 NEISSERIA SICCA, WAS TESTED VIA API NH STRIPS. THE RESULTS WERE COMPLIANT WITH A "VERY GOOD IDENTIFICATION" TO NEISSERIA SPP AT 99.9%. ANALYSIS OF THE BATCH RECORD, INCLUDING BACTERIOLOGICAL TESTS, INDICATES ALL CRITERIA FOR RELEASE WERE COMPLIANT. ACCORDING TO THE PACKAGE INSERT REV 07487P-XL-2016/12 (CURRENT VERSION), THE KNOWLEDGE BASE OF THE STRIP IS LIMITED TO NEISSERIA SPP. COMPLEMENTARY TESTS ARE NECESSARY TO IDENTIFY THE GENUS TO NEISSERIA SICCA. CONCLUSION: DUE TO THE EXPIRATION OF THE IMPACTED API NH STRIPS, TESTING COULDN'T BE PERFORMED IN THE BIOMÉRIEUX QC LABORATORY. HOWEVER, A PREVIOUS STUDY ON STRAIN ATCC 9913 NEISSERIA SICCA AT BIOMÉRIEUX SHOWED THIS STRAIN IS CORRECTLY IDENTIFIED WITH THE API NH STRIPS.

Description of Event or Problem

A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH API NH (REFERENCE 10400). THE CUSTOMER REPORTED THE EXPECTED IDENTIFICATION AS NEISSERIA SICCA AND THE ACTUAL RESULT WAS NEISSERIA GONORRHOEA 98% (GOOD ID). REPEAT TESTING CONFIRMED THE MISIDENTIFICATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.