LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex 628930Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888234400462), received between May 24, 2018 and Feb 27, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2019Missing Test Results; Missing Test Results

  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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373640 ↗
• MalfunctionJul 25, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CUSTOMER COMPLAINT ((B)(4)) WAS RECEIVED 02MAY2017 VIA PRODUCT DISTRIBUTOR THAT CUSTOMER IS HAVING ISSUES WITH LIFECODES HLA-DQA1B1 SSO TYPING KIT (628930), LOT 10205A. CUSTOMER REPORTS THAT MULTIPLE INDETERMINATE PROBES (WEAK REACTIVITY), SPECIFICALLY BEADS 242, 274, 281, AND 292 ARE NOTED AS FALLING BELOW THE LOT SPECIFIC CUT-OFF VALUE. PER THE PRODUCT IFU, 2 PROBES MAY BE INDETERMINATE (FALLING BELOW THE LOT SPECIFIC CUT-OFF VALUE). FOR THIS ASSAY, 4 PROBES WERE INDETERMINATE, THEREFORE INVALIDATING THE ASSAY. IT IS NOT KNOWN IF THE CUSTOMER RECOGNIZED THAT THIS ASSAY WAS INVALID DUE TO THE 4 PROBES RESULTING AS INDETERMINATE. THE CUSTOMER PERFORMS THE ASSAY WITH SEVERAL VARIATIONS FROM THE PROTOCOL DESCRIBED IN THE LIFECODES HLA-DQA1B1 SSO TYPING KIT IFU (INSTRUCTIONS FOR USE). ALTERNATE METHOD TO PREPARE SAMPLE VOLUME USED IN THE ASSAY, DNA CONCENTRATION IS NOT QUANTIFIED IT IS EXPECTED THE RANGE THEY USE MEETS THE ASSAY DEFINED RANGE, ALTERNATE VENDOR AMPLIFICATION PLATES ARE USED. DATA PROVIDED BY THE CUSTOMER POINTS TO ISSUES WITH TECHNIQUE/EQUIPMENT AND NOT WITH KIT. ADDITIONAL QUESTIONS ASKED OF CUSTOMER WERE NOT RESPONDED TO. ROOT CAUSE OF WEAKLY REACTIVE PROBES IN LIFEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7720742 ↗
• MalfunctionJul 24, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CUSTOMER CONTACTED IMMUCOR TECHNICAL SUPPORT (COMPLAINT #(B)(4)) THAT SAMPLES ON THE LIFECODES HLA-DQA1/B1 SSO TYPING KIT (628930), LOT # 3004970 HAD DISCREPANT RESULTS. SAMPLE WAS RESULTING AS DQB1*06:09:01:01 HOMOZYGOUS. IT WAS SUBSEQUENTLY IDENTIFIED THAT THE SAMPLE WAS NOT HOMOZYGOUS BUT FOUND TO BE DQB1 *06:09:01:01, *03:03:02:01. THE CUSTOMER WAS NOT FOLLOWING THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE CUSTOMER WAS NOT USING FULL VOLUMES OF REAGENTS. THE CUSTOMER IDENTIFIED THE ISSUE BECAUSE THE OBTAINED RESULTS DID NOT FIT WITH THE HLA-DR ASSOCIATIONS THEY SHOULD MATCH. THE CUSTOMER REPEATED THE TESTING WITH AN ALTERNATE METHOD (SSP) AND DISCOVERED A HLA-DQ6, DQ3 RESULT RATHER THAN THE HLA-DQ6 HOMOZYGOTE. THE CUSTOMER INFORMED IMMUCOR THAT THEY PERFORMED AN INVESTIGATION TO CHECK FOR PATIENT HARM BUT HAVE FOUND NO CAUSE FOR PATIENT HARM. CUSTOMER IS NOT FOLLOWING THE IFU AND WAS AWARE OF POTENTIAL RISKS INVOLVED IN DOING THIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716242 ↗
• MalfunctionJul 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  CUSTOMER CONTACTED IMMUCOR ON (B)(6) 2018 ((B)(4)) REGARDING A SAMPLE IN WHICH AN ALLELE DROPOUT WAS SUSPECTED WITH LIFECODES HLA-DQA1/B1 SSO TYPING KIT LOT 3004970. THE SAMPLE WAS TESTED AND ORIGINALLY RESULTED IN A DQB1 TYPING OF DQ5 HOMOZYGOUS WITH AN EXACT MATCH BY THE SOFTWARE. THE CUSTOMER SUSPECTED A POSSIBLE ALLELE DROPOUT WITH THE SAMPLE AND RETESTED THE SAMPLE WITH SEQUENCE-SPECIFIC PRIMER (SSP). THIS RESULTED IN A DQB1 HETEROZYGOUS TYPING OF DQ5/DQ9. THE SAMPLE WAS THEN RETESTED BY LIFECODES SSO, RESULTING IN A REVIEW PROBES PROMPT BY THE SOFTWARE. THE SAMPLE REQUIRED TWO MANUAL BEAD CHANGES TO RESULT IN THE HETEROZYGOUS TYPING DQ5/DQ9. THE CUSTOMER STATED THAT THEY FOLLOW IMMUCOR PRODUCT STORAGE AND IFU PROTOCOLS. THE INCORRECT TYPING WAS NOT REPORTED OUT BY THE CUSTOMER. THE SAMPLE WAS REPEATED AND THE CORRECT RESULTS REPORTED OUT. THE CUSTOMER DECIDED TO REPEAT THE SAMPLE TESTING BY BOTH SSP AND SSO DUE TO KNOWN GENE LINKAGES AND ALSO BECAUSE WHAT THE CUSTOMER CONSIDERS FALSE NEGATIVE DQ3 PROBES, WERE WITHIN 30% RANGE FROM THRESHOLD FOR THE SAMPLE. THE CUSTOMER WILL CONTINUE TO MONITOR THIS ISSUE.

  Patient problems: Missing Value Reason; No Information

  MAUDE report 7707535 ↗
• MalfunctionMay 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IMMUCOR RECEIVED A CUSTOMER COMPLAINT ON 26 FEBRUARY 2018 ((B)(4)) FROM A CUSTOMER THAT CONTACTED IMMUCOR REGARDING EIGHT SAMPLES ACROSS THREE RUNS THAT GENERATED A MISTYPE WITH LIFECODES HLA-DQA1/B1 SSO TYPING KIT (LOT 3006117). THE CUSTOMER REPORTS THAT FOR THESE SAMPLES THE DQA PROBE 207 WAS FALSE NEGATIVE RESULTING IN DQA SAMPLE MISTYPE FOR DQA1*02. IN ALL CASES, THE SAMPLES WERE TYPED AS DQA1*01 HOMOZYGOUS BY LIFECODES HLA-DQA1/DQB1 SSO TYPING KIT LOT 3006117. THE SAMPLES WERE REPEATED FOR DQA LOCUS BY THE CUSTOMER ON SSP/LINKSEQ AND THE REPEAT TYPING RESULTS WERE DQA1*01, DQA1*02. THE CUSTOMER INFORMED IMMUCOR THAT NO INCORRECT RESULTS WERE REPORTED. THE CUSTOMER CHOSE TO REPEAT THE TYPINGS BY ANOTHER METHOD DUE TO PROBE 207 BEING CLOSE TO THE THRESHOLD AND DUE TO KNOWN GENE ASSOCIATIONS WITH DRB1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542134 ↗