AN INTERNAL BIOM?RIEUX INVESTIGATION WAS CONDUCTED. RESULTS ARE AS FOLLOWS: A DIFFERENCE OF QUANTIFICATION UP TO 1 LOG AND SOMETIME MORE THAN 1 LOG WAS OBSERVED , WHICH CAN BE SIGNIFICANT ON RESULTS. AS THE DOWNSTREAM APPLICATIONS ARE QUALITATIVE AND/OR QUANTITATIVE METHODS, THE DECREASE IN PERFORMANCES IN DOWNSTREAM APPLICATION COULD LEAD TO: A RISK OF FALSE NEGATIVE, FOR QUALITATIVE TESTS. INVALID RESULTS, WHEN EXTRACTED AND AMPLIFIED INTERNAL CONTROL IS NOT WITHIN SPECIFICATIONS. UNDER-QUANTIFICATION FOR VIRAL LOAD RESULTS FOR QUANTITATIVE TESTS. DURING THE INVESTIGATION, WE CONFIRMED THE ISSUE FOR THE FOLLOWING SPECIFIC CUSTOMER'S APPLICATIONS: IMPACT WHEN USING A HIGH SAMPLE INPUT VOLUME, FROM 200UL AND UP TO 1 ML. IMPACT WHEN DOUBLE STRANDED NUCLEIC ACID APPLICATIONS WITH SMALL (
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Patient 1
A CUSTOMER REPORTED A DISCREPANT RESULT WHEN USING THE NUCLISENS MAGNETIC SILICA REAGENT. THE INTERNAL CONTROL OF THE ELUATE DID NOT PASS THE REQUIRED CUSTOMER CRITERIA. WHEN SPECIFICALLY ASKED, THE CUSTOMER INDICATED THAT NO DEATH, INJURY OR MISTREATMENT WAS ASSOCIATED WITH THIS ISSUE. THE CUSTOMER DID INDICATE A DELAY OF RESULTS OF AN INDETERMINATE AMOUNT OF TIME AS A RESULT OF NEEDING TO RERUN THE SAMPLES. BIOMERIEUX HAS INITIATED AN INVESTIGATION INTO THIS ISSUE.