LIFECODES HLA-B SSO Typing Kit for use with Luminex 628915Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234400028), received between May 24, 2018 and Nov 19, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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.

• MalfunctionNov 19, 2020Incorrect Measurement; Use of Device Problem; Improper or Incorrect Procedure or Method; Incorrect Measurement; Use of Device Problem; Improper or Incorrect Procedure or Method

  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 A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10868731 ↗
• MalfunctionJul 25, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2017, CUSTOMER CALLED TECHNICAL SUPPORT WITH COMPLAINT (B)(4) REPORTING THAT THE MI DNA SOFTWARE IS CALLING B*08:04, 51:01, WHILE SSP, SEQUENCE SPECIFIC PRIMER ASSAY (ALTERNATE ASSAY) SHOWS B*08:01, 51:01 RESULT. THE CUSTOMER WAS PERFORMING THE ASSAY AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE COMPLAINT IS PERTINENT TO THE ASSAY, NOT THE SOFTWARE, SPECIFICALLY LIFECODES HLA-B SSO TYPING KIT (628915), LOT 06036A. THREE ASSAY FILES WERE PROVIDED. THE PROBES IN QUESTION WERE PROBES 204, 207, 218, 296 WHICH RESULTED WITH BORDERLINE REACTIVITY. PROBE 207 WAS OVERRIDDEN WITH RESULT DETERMINED TO BE B*08:04, 51:01. ADJUSTMENT TO OVERRIDDEN PROBES RESULT IN ALTERNATE IDENTIFICATION FOR THE 08 ALLELE, EITHER B08:04, B08:65, B 08:23 OR B08:01. THE CSV FILES OBTAINED FROM THE CUSTOMER WERE REVIEWED INCLUDING ALLELE COMPARISON IN THE SOFTWARE AND CONFIRMED THAT WHEN PROBES 204, 207 AND 218 ARE NEGATIVE THE TYPING IS B*08:01, 51:01. ALL THREE PROBE ARE WITHIN THE 10% OF THE CUTOFF. THIS RETYPING MATCHES SSP RESULTS. THE 08:04, 08:65, 08:23 HAVE ONE MISMATCH DIFFERENT FROM 08:01 REFERENCE. THE REST OF THE SEQUENCE IS IDENTICAL FOR ALL FOUR ALLELES. THIS EXPLAINS WHY THERE IS NOT A UN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7719516 ↗
• MalfunctionMay 24, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CUSTOMER COMPLAINT WAS RECEIVED ON MARCH 2, 2018 ((B)(4)) DESCRIBING THAT WHEN REPORTS WERE GENERATED USING PRODUCT NUMBER 628915, LOT NUMBER 01117A OF LIFECODES HLA-B SSO TYPING KIT THE SEROLOGICAL EQUIVALENT FOR B*27:08 WAS SHOWN TO BE BW4 RATHER THAN THE CORRECT BW6. IMMUCOR GTI DIAGNOSTICS QUALITY CONTROL REVIEWED THE COMPLAINT AND DISCOVERED THAT THE CHANGE WAS DUE TO A TRANSCRIPTION ERROR DURING CREATION OF HLA-B PROBE HIT TABLES FOR 3.29.0 ALLELE DATABASE SEROLOGICAL EQUIVALENCE FILE OF THE DATABASE FILES. THE HLA-B ALLELE B*27:08 SEROLOGICAL EQUIVALENCE CHANGED FROM A B27 (BW6) IN ALLELE DATABASE 3.27.0 TO B2708 (BW4) IN ALLELE DATABASE 3.29.0. THE HLA-B ALLELE B*27:08 SEROLOGICAL EQUIVALENCE WAS INCORRECTLY ASSIGNED BW4. AN NCR (NCR 1762) WAS OPENED TO ADDRESS THE ISSUE. RESOLUTION OF THIS ERROR WAS MADE WITH A CORRECTION TO THE DATABASE, A CUSTOMER NOTIFICATION (CORRECTION) AND A TECHNICAL UPDATE LOADED TO THE IMMUCOR WEBSITE FOR THE AFFECTED LOTS OF PRODUCT. THE SEROLOGICAL EQUIVALENT (BW4 OR BW6) IS ASSIGNED BY THE WORLD HEALTH ORGANIZATION (WHO). LIFECODES HLA SSO-B TYPING KIT OR LIFECODES HLA SSO-BERES AFFECTED KITS: PRODUCT NAME: LIFECODES HLA-B SSO TYPING KIT, LOT#/

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542142 ↗