LIFECODES HLA-B SSO TYPING KIT

Description of Event or Problem

CUSTOMER REPORTED A MISTYPED SAMPLE FOR LIFECODES HLA-B SSO TYPING KIT LOT 3008083, SAMPLE ID (B)(4), TESTED ON (B)(6) 2020. THE RESULTS ON THE FIRST RUN WERE (B)(6) . THERE WERE MANY FAILED SAMPLES (7 OUT OF 10) DURING THIS RUN WHICH LED THE USER TO RE-READ THE ASSAYS. ADDITIONALLY THE SAMPLE IN QUESTION HAD FAILED AMPLIFICATION FOR HLA-A AND HLA-C LOCI. THE CUSTOMER DID NOT RUN A POSITIVE CONTROL WITH THE ASSAY. A NEW SAMPLE WAS OBTAINED AND TESTED ALONG WITH THE ORIGINAL SAMPLE ON (B)(6) 2020. THE TYPING WAS (B)(6) FOR BOTH THE ORIGINAL AND NEW SAMPLE. THIS RESULT, FOR THE REPEAT TESTING OF THE ORIGINAL SAMPLE AND A NEW SAMPLE HAS BEEN CORRECTED TO THE ORIGINAL REPORT. PRIOR TO THE SECOND TESTING EVENTS, THE CUSTOMER PERFORMED MAINTENANCE ON THE LUMINEX INSTRUMENT. DUE TO THE ORIGINAL TESTING EVENT ENCOUNTERING 7 OF 10 SAMPLES AS HAVING FAILED AMP (NOT INCLUDING THE SAMPLE IN QUESTION), THIS MAY BE INDICATIVE TO TECHNICAL ERROR DURING TESTING. THE NATURE OF THE ERROR CANNOT BE DETERMINED FROM THE RAW DATA. THE CUSTOMER HAS BEEN INFORMED TO RUN A POSITIVE CONTROL AND WHEN REVIEWING SAMPLES TO CHECK FOR COMMON HAPLOTYPES. WITHIN THE IFU, IT IS RECOMMENDED TO INCLUDE ONE NEGATIVE AND POSITIVE CONTROL. VALUES ARE INCLUDED IN THE IFU FOR CONSENSUS PROBES TO EXCEED VALUES SET FORTH IN PRODUCT LABELING. THERE IS NO HARM KNOWN OR EXPECTED TO THE PATIENT DUE TO THE FIRST RESULT REPORTING. COMPLAINT ID# (B)(4).