LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex 628917Recalls & reported problems
Immucor Gti Diagnostics, Inc. · DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234400035), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (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
Device problems
- Off-Label Use1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2018Off-Label Use; Off-Label Use
CUSTOMER HAS REPORTED ((B)(4)) TO THE TECHNICAL SALE SPECIALIST ON AUGUST 2, 2018, DURING A ROUTINE VISIT THAT THE HLA-B ALLELE ASSIGNMENTS FOR SAMPLE (B)(6) OBTAINED USING LIFECODES HLA-B ERES SSO TYPING KIT (LOT 01117B), DID NOT AGREE WITH THE PATIENT FIRST DNA SAMPLE ASSIGNMENT WHICH WAS OBTAINED USING AN ALTERNATE VENDOR'S KIT BACK IN 2015. THE ALLELES ASSIGNED FOR SAMPLE (B)(6) ON (B)(6) 2018 WERE HLA-B*57:04 HOMOZYGOUS COMPARED TO HLA-B*57:04, B*15:01 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-B*57:04 HOMOZYGOUS FOR SAMPLE (B)(6) AND HLA-B*57:04, B*15:01 HETEROZYGOUS FOR THE SAMPLE. AS PART OF THE SAME INTERNAL INVESTIGATION SAMPLE (B)(6)7 WAS TESTED USING PCR-SSP WHICH GAVE HLA-B*57:04, B*15:01 HETEROZYGOUS ASSIGNMENT SIMILAR TO THE ALTERNATE VENDOR'S 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 PROTOCOL INDIC
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7833214 ↗
Other Test,Qualitative,For Hla,Non-Diagnostic devices
- DonorScreen-HLA® Class I and Class II DSI+IIImmucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic6 reports
- LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex 628930Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic5 reports
- LIFECODES HLA-B SSO Typing Kit for use with Luminex 628915Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic3 reports
- LIFECODES MATCH IT!™ DNA Software v1.2 888623Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic3 reports
- N/A 340183Becton, Dickinson And Company · Test, qualitative, for HLA, non-diagnostic2 reports
- LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex 628921Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic2 reports
- LIFECODES Class I ID Typing Kit for use with Luminex 628200Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic1 report
- LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine 628923Immucor Gti Diagnostics, Inc. · Test,Qualitative,For Hla,Non-Diagnostic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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