API RAPID ID 32 E 25STRIPS

Additional Manufacturer Narrative

IN RESPONSE TO THE CUSTOMER COMPLAINT BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. A REVIEW OF THE API® DATA DETERMINED CRONOBACTER SPP. CANNOT BE IDENTIFIED WITH THE API® RAPID ID 32 E 25STRIPS. INTERNAL QUALITY CONTROL TESTING WAS PERFORMED IN TRIPLICATE USING IMPACTED LOT 1007739570 AND REFERENCE LOT 1007999700. THE ORGANISMS TESTED WERE KLEBSIELLA OXYTOCA CQ104 ATCC¿ 43863, PROTEUS MIRABILIS CQ106 ATCC¿ 35659, AND MORGANELLA MORGANII CQ116 ATCC¿ 25829. ALL RESULTS FROM BOTH LOTS WERE WITHIN SPECIFICATION. THE IMPACTED STRAIN WAS REQUESTED BUT NOT SUBMITTED.

Description of Event or Problem

AN INDUSTRY CUSTOMER IN (B)(6)NOTIFIED BIOMÉRIUX OF A MISIDENTIFICATION OF CRONOBACTER STRAINS AS ENTEROBACTER CLOACAE SPECIES IN ASSOCIATION WITH THE API® RAPID ID 32 E 25STRIPS (REF. (B)(4), LOT. 1007739570) WHEN TESTING COLONIES ORIGINALLY SOURCED FROM MILK POWDER. THE SAMPLE WAS TESTED USING GENE-UP WHICH OBTAINED A CRO POSITIVE RESULT. THE ORGANISM WAS THEN SUBCULTURED ONTO ESIA AGAR BLUE-GREEN COLONIES WERE OBSERVED INDICATING CRONOBACTER. THEN COLONIES WERE SUBCULTURED ON A NUTRITIVE AGAR AND THE CONFIRMATION OF THE IDENTIFICATION PERFORMED WITH THE IMPACTED LOT OF RAPID ID 32 E STRIPS THAT GAVE ENTEROBACTER CLOACAE SPECIES INSTEAD OF CRONOBACTER AS EXPECTED. AS THERE IS NO PATIENT ASSOCIATED WITH THIS INDUSTRY STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.