D
Patient 1
A CUSTOMER IN THE NETHERLANDS CONTACTED BIOM?RIEUX TO REPORT DISCREPANT RESULTS WITH NUCLISENS MAGNETIC EXTRACTION REAGENT PRODUCT INVOLVING A RECOVERY ISSUE WITH THE SILICA. THE CUSTOMER, AN INDUSTRY FOOD LABORATORY THAT FOLLOWS ISO 15216 FOR VIRUS DETECTION IN FOOD, USES A BIB PROCESS CONTROL OF A SIMILAR VIRUS THAT THEY WANT TO DETECT AND THIS SIMILAR VIRUS IS SPIKED (B)(6)SAMPLE. THE CUSTOMER REPORTED A DIFFERENCE WITH RESPECT TO THE INTERNAL QUALITY CONTROL BETWEEN THE RECALLED BATCH (IDENTIFIED AS "BAD BATCH")AND THE NEW BATCH (IDENTIFIED AS "GOOD BATCH) AS FOLLOWS: (B)(6). THE CUSTOMER INDICATED A SHIFT OF ABOUT (B)(6) BETWEEN THE GOOD AND BAD BATCHES. INDICATING THAT WITH A LOW AMOUNT OF VIRUS IN THEIR SAMPLE THEY COULD HAVE ENCOUNTERED (B)(6) RESULTS. THE CUSTOMER INDICATED THE TARGET VIRUS AS (B)(6) , EXTRACTION OF RNA FROM (B)(6) OF EACH FOOD SAMPLE USING AN APPROPRIATE GUANIDINE THIOCYANATE DISRUPTION AND SILICA ABSORPTION-BASED METHOD. THE INTERNAL CONTROL WAS INDICATED AS A PROCESS CONTROL VIRUS STOCK SIMILAR TO THE VIRUS TO DETECT. THE CUSTOMER CONFIRMED NOT RECEIVING FALSE RESULTS ONLY LOWER RECOVERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT, BECAUSE THE CUSTOMER IS AN INDUSTRY (NON-CLINICAL CUSTOMER). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT. BIOM?RIEUX INVESTIGATION WILL BE INITIATED.