LIFECODES MATCH IT!™ DNA Software v1.2 888623Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234400394), received between Jan 19, 2018 and Mar 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2021Computer Software Problem; Computer Software Problem

  EFS ANGERS REPORTED AN ERROR WITH A LIST OF AMBIGUITIES WITH IMGT 3.41 AND MATCHIT! DNA SOFTWARE V1.3. THEY USED MATCHIT! DNA SOFTWARE V1.3 ACCORDING TO THE IFU. THEY COMPARED THE REPORT FOR ONE SAMPLE ((B)(6)) IN IMGT 3.39 AND IMGT 3.41. THE LIST OF AMBIGUITIES IS INEXACT, THE LIST LOST SOME OF THE ALLELE COMBINATIONS THAT WERE LISTED IN THE FILES. UPON INVESTIGATION, IT WAS DISCOVERED THAT ALLELES WERE BEING TRUNCATED ON IMPORT OF EXP FILES. A SQL FUNCTION, UTILFN_SPLIT, INVOLVED IN THE IMPORT IS LIMITING THE NUMBER OF CHARACTERS TO 4000 CHARACTERS. THIS AFFECTS THE ALLELES THAT ARE IMPORTED INTO MATCH IT!, LIMITING THE ALLELES FOR SOME LOCI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404597 ↗
• MalfunctionFeb 10, 2021Computer Software Problem; Computer Software Problem

  THIS IS A FOLLOW UP TO THE INITIAL REPORT #2183608-2021-00001. EFS CRETEIL (ILE DE FRANCE) REPORTED AN ERROR WITH A LIST OF AMBIGUITIES ON IMGT 3.39V2 AND MATCHIT! DNA SOFTWARE VERSION 1.2.4 WHICH SHOWED A NON-CONFORMITY IN THE RESULT. THE TYPING RESULT GIVEN BY NEXT GENERATION SEQUENCING OMIXON IS A*24:02,A*24:314. THE LIFECODES HLA SSO TYPING RESULT GAVE THE SAME RESULT AS OMIXON IN G GROUP:A*24:02,24:26. FOR INFORMATION A*24:26 AND A*24:314 ARE PART OF SAME G GROUP, A*24:26G, A*24:26 OR A*24:314 HAVE THE SAME PROBE HIT IN ALLELE COMPARISON IN LIFECODES HLA-A STANDARD AND LIFECODES HLA-AERES. WHEN THE LOCUS RESULTS OF LIFECODES HLA-AERES IS MERGED TO THE LOCUS RESULTS OF LIFECODES HLA-A STANDARD, THE LIST OF ALLELES DOES NOT CONTAIN THE ALLELE A*24:314. THE CUSTOMER TRIED TO ANALYZE THE CSV RESULT WITH IMGT 3.41 AND THE SAME ERROR OCCURRED. WHEN RUN WITH LIFECODES HLA-A SSO TYPING KIT THE RESULTS WERE CORRECT, BUT WHEN THE LOCUS RESULTS WERE MERGED A*24:314 WAS NO LONGER PRESENT. UPON INVESTIGATION, IT WAS DISCOVERED THAT ALLELES WERE BEING TRUNCATED ON IMPORT OF EXP FILES. A SQL FUNCTION, UTILFN_SPLIT, INVOLVED IN THE IMPORT IS LIMITING THE NUMBER OF CHARACTERS TO 4000 CHARACTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307749 ↗
• MalfunctionJan 19, 2018Computer Software Problem; Computer Software Problem

  THE (B)(6) HAS REPORTED A COMPLAINT ((B)(4)) ON (B)(6) 2017 THAT WHEN USING MATCH IT! DNA SOFTWARE V1.2.3 FOR HLA-A TYPING, THEY HAVE OBSERVED FOR 1 SAMPLE THAT THE SOFTWARE DOES NOT CORRECTLY LOAD THE SUGGESTED ASSIGNMENT TABLE WHEN NAVIGATING BETWEEN SAMPLES THAT CONTAIN COMPLEX NUMBERS OF HLA-A ALLELE-STRING PAIRS (OBSERVED WITH HLA-A*02 HOMOZYGOUS SAMPLES). THE ERROR OCCURS WHEN USING PAIRWISE OFF WITH A WIN 7 32-BIT COMPUTER, USING 3.27 ALLELE DATABASE. WHEN THE USER NAVIGATES FROM ONE SAMPLE TO THE NEXT SAMPLE, THE SOFTWARE DOES NOT AUTOMATICALLY ASSIGN A TYPING INTO THE ASSIGNED VIEW FIELD WHEN THE AUTO ASSIGN FEATURE IS ACTIVATED IN PREFERENCES. IF THE USER ATTEMPTS TO MAKE A MANUAL ASSIGNMENT TO THE ASSIGNED VIEW FIELD, THE SOFTWARE WILL CRASH. DURING THE COURSE OF THE INVESTIGATION WITH THE CUSTOMER, THE USER'S SOFTWARE WAS UPDATED FROM V1.2.3 TO V1.2.4. AN ERROR STILL OCCURS IN V1.2.4, HOWEVER IN THIS VERSION THE WHEN THE USER NAVIGATES FROM ONE SAMPLE TO THE NEXT SAMPLE, THE SOFTWARE MAINTAINS THE PREVIOUS SAMPLE TYPING IN THE ASSIGNED VIEW IN ADDITION TO THE SUGGESTED ASSIGNMENTS. IF THE USER ATTEMPTS TO MAKE A MANUAL ASSIGNMENT, THE SOFTWARE WILL FREEZE HOWEVER THERE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7207186 ↗