LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex 628921Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234400059), received between May 24, 2018 and Aug 29, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2018Off-Label Use; Off-Label Use

  CUSTOMER HAS REPORTED (B)(4) TO THE TECHNICAL SALE SPECIALIST ON (B)(6) 2018, DURING A ROUTINE VISIT THAT THE HLA-C ALLELE ASSIGNMENTS OBTAINED USING LIFECODES HLA-C ERES SSO TYPING KIT (LOT 01317B) FOR SAMPLE (B)(4) DID NOT AGREE WITH THE PATIENT FIRST DNA SAMPLE ASSIGNMENT WHICH WAS OBTAINED USING AN ALTERNATE VENDOR KITS BACK IN 2015. THE ALLELES ASSIGNED FOR SAMPLE (B)(4) ON (B)(6) 2018 WERE HLA-C*18:01 HOMOZYGOUS COMPARED TO HLA-C*18:01, C*03:03 FOR THE FIRST SAMPLE BY THE ALTERNATE VENDOR'S KIT BACK IN 2015. THE CUSTOMER INDICATED AS PART OF THEIR INTERNAL INVESTIGATION, THEY REPEATED THE SAMPLE USING THE ABOVE MENTIONED LOT NUMBER AND GOT SIMILAR RESULTS I.E. HLA-C*18:01 HOMOZYGOUS FOR SAMPLE (B)(4) AND HLA-C*18:01, C*03:03 HETEROZYGOUS FOR THE SAMPLE. AS PART OF THE SAME INTERNAL INVESTIGATION SAMPLE (B)(4) WAS TESTED USING PCR-SSP, HLA SEQUENCING ASSAY, WHICH GAVE HLA-C*18:01, C*03:03 HETEROZYGOUS ASSIGNMENT SIMILAR TO THE ALTERNATE VENDOR ASSIGNMENT BACK IN 2015. IMMUCOR TECHNICAL SUPPORT IDENTIFIED THAT THE CUSTOMER WAS USING THE PRODUCT OFF LABEL WHERE SET UP OF THE ASSAY WAS USING A 1/2 VOLUME PROTOCOL. THE CUSTOMER WAS ADVISED TO RETEST THE SAMPLE USING THE STANDARD P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7830593 ↗
• MalfunctionMay 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A COMPLAINT ((B)(4)) WAS RECEIVED ON (B)(6) 2017, WHERE THE CUSTOMER REPORTED THAT LIFECODES HLA-CERES SSO TYPING KIT (LOT 08056C) GAVE A RESULT THAT WAS NOT CONCORDANT WITH SEQUENCE BASED TYPING. THE CLINICAL SAMPLE GAVE THE FOLLOWING WHEN TESTED WITH SEQUENCE BASED TYPING: HLA-C (C*01:115, C*04:01). THIS RESULT WAS NOT CONSISTENT WITH THE RESULT OBTAINED WHEN THE SAMPLE WAS TESTED WITH LIFECODES HLA-CERES LOT 08056C 12/10/2020 (B)(4). NOTIFICATION FROM FDA WAS RECEIVED ON NOVEMBER 27, 2020 NOTIFYING IMMUCOR GTI DIAGNOSTICS THAT THIS INITIAL REPORT WAS NOT RECEIVED WHEREAS A FOLLOW UP 2 REPORT WAS. SUBMISSION OF THIS REPORT IS BEING PROVIDED PER DIRECTION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 7542139 ↗