VITEK® 2 NH TEST KIT

Description of Event or Problem

A CUSTOMER FROM FRANCE REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF A CAMPYLOBACTER JEJUNI JEJUNI STRAIN (ATCC 33560 LOT 111-38-1) AS CAMPYLOBACTER COLI IN ASSOCIATION WITH THE VITEK® 2 NH TEST KIT (UDI (B)(4)). THE CUSTOMER TESTED THE STRAIN AT 24 AND 48 HOURS IMMEDIATELY AFTER INCUBATION. THE CUSTOMER OBTAINED A RESULT OF LOW DISCRIMINATION AND SELECTED CAMPYLOBACTER JEJUNI JEJUNI WITHOUT COMPLEMENTARY TESTING. THE SECOND TEST RESULT WAS CAMPYLOBACTER COLI. THE CONFORMING QUALITY CONTROL ID WAS EIKENELLA CORRODENS. THERE WAS NO PATIENT INVOLVEMENT AS THE CUSTOMER WAS PERFORMING A CONTROL TEST FOR CAMPYLOBACTER STRAINS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF CAMPYLOBACTER JEJUNI SSP JEJUNI ATCC® 33560¿ AS CAMPYLOBACTER COLI IN ASSOCIATION WITH THE VITEK® 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT. INVESTIGATIONAL TESTING WAS PERFORMED USING TWO ATCC® 33560¿ STRAINS (S1 AND S2) SUBMITTED BY THE CUSTOMER, AS WELL AS THE INTERNAL BIOMÉRIEUX ATCC® 33560¿ STRAIN (S3). IT SHOULD BE NOTED THAT THIS ATCC® STRAIN IS NOT A QC STRAIN INTENDED FOR THE NH ID CARD. INVESTIGATIONAL TESTING INCLUDED: VITEK® MS: OBTAINED IDENTIFICATION TO CAMPYLOBACTER JEJUNI FOR ALL THREE ATCC® STRAINS. VITEK® 2 NH ID (CUSTOMER LOT 2450162203): S1 - VERY GOOD IDENTIFICATION TO CAMPYLOBACTER COLI. S2 - VERY GOOD IDENTIFICATION TO CAMPYLOBACTER COLI. S3 - VERY GOOD IDENTIFICATION TO CAMPYLOBACTER COLI. VITEK® 2 NH ID (RANDOM LOT 245398920): S1 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. S2 - LOW DISCRIMINATION BETWEEN C. COLI, C. JEJUNI SSP JEJUNI AND C. FETUS SSP FETUS. S3 - EXCELLENT IDENTIFICATION TO CAMPYLOBACTER COLI. THE INVESTIGATION REPRODUCED THE CUSTOMER RESULTS 83% OF THE TIME. THE INVESTIGATION CONCLUDED CAMPYLOBACTER JEJUNI SSP JEJUNI ATCC® 33560¿ IS AN ATYPICAL STRAIN FOR TESTING VIA THE VITEK® 2 NH ID CARD. AS PREVIOUSLY NOTED, THIS ATCC® STRAIN IS NOT A QC STRAIN INTENDED FOR THE NH ID CARD.