LIFECODES HLA DQAB

Description of Event or Problem

CUSTOMER REPORTS INCORRECT RESULT WITH SAMPLES TESTED WITH LIFECODES DQAB SSO LOT 3006951. CUSTOMER REPORTS 2 SAMPLES GAVE RESULTS DISCORDANT WITH SSP SAMPLE 18-1203: DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(4). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS IMGT 3.33 DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED. CSV FILES AND SSP DOCUMENTS ATTACHED.

Additional Manufacturer Narrative

SMP #1 THE SAMPLE CONFIRMED ISSUE. 28FEB2019 (B)(6). SAMPLES RECEIVED AND INTERNAL TESTING COMPLETED. SAMPLE 18-1203: TESTING WITH LIFECODES HLA DQAB SSO GAVE HLA DQA TYPING DQA1*01:XX DQB1*01:XX. IN ORDER FOR RESULTS TO BE CONCORDANT WITH SSP (DQA1*01:03 DQA1*02:01) PROBE 207 SHOULD BE ASSIGNED AS POS. PROBE 207 ASSIGNED AS NEGATIVE WITH ADJUST VALUE FALLING AT 18% AND 24 % BELOW LOT-SPECIFIC CUT-OFF IN RESPECTIVE REPLICATES. CUSTOMER OBSERVATION WAS REPRODUCED. SMP #2 THE SAMPLE DID NOT CONFIRM AND TESTED CONCORDANT 28FEB2019 (B)(6). SAMPLES RECEIVED AND INTERNAL TESTING COMPLETED. SAMPLE 18-1174: TESTING WITH LIFECODES HLA DQAB SSO GAVE HLA DQB TYPING DQB1*03:XX DQB1*05:XX. THIS RESULT IS CONCORDANT WITH RESULT OBTAINED BY CUSTOMER WITH SSP TESTING. PROBES 242, 274, 281, AND 292 WERE ALL ASSIGNED AS POSITIVE AND GREATER THAN 30% FROM LOT SPECIFIC CUT-OFFS IN BOTH REPLICATES. CUSTOMER OBSERVATION WAS NOT REPRODUCED.

Additional Manufacturer Narrative

SAMPLE (B)(6): DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(6). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS (B)(6) DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED.

Description of Event or Problem

CUSTOMER REPORTS INCORRECT RESULT WITH SAMPLES TESTED WITH LIFECODES DQAB SSO LOT 3006951. CUSTOMER REPORTS 2 SAMPLES GAVE RESULTS DISCORDANT WITH SSP SAMPLE (B)(6): DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(6). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS (B)(6) DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED.