LIFECODES Class I ID Typing Kit for use with Luminex 628200Recalls & reported problems
Immucor Gti Diagnostics, Inc. · LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA) · 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 10888234400295), received between Jul 31, 2018 and Jul 31, 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.
MalfunctionJul 31, 2018Off-Label Use; Off-Label Use
COMPLAINT (B)(4) FOR LIFECODES CLASS I ID (628200), LOT # 3006385 WAS RECEIVED ON JULY 6, 2018. THE CUSTOMER REPORTS PATTERN OF POSITIVE RESULTS FOR HISTORICALLY NEGATIVE PATIENTS WHEN TESTED WITH CLASS I ID LOT 3006385. THE LAB'S SOP REQUIRES THAT ALL SAMPLES ARE PRE-TREATED WITH DTT (DITHIOTHREITOL) PRIOR TO TESTING. CUSTOMER HAS BEEN INFORMED THAT PRE-TREATMENT WITH DTT IS NOT A VALIDATED PROCESS AND IS CONSIDERED OFF-LABEL USE. IMMUCOR TECHNICAL SUPPORT REQUESTED THE CUSTOMER RUN THE SAMPLES NEAT (WITHOUT PRE-TREATMENT). CUSTOMER STATED THAT THEY WILL NOT PERFORM ANY TROUBLE-SHOOTING AT THIS TIME BUT WOULD LIKE IMMUCOR TO ADDRESS THIS ISSUE IN THEIR MANUFACTURING PROCESSES. CUSTOMER CONFIRMS NO PATIENT HARM. CUSTOMER REPORTED THE RESULTS BECAUSE THE ASSAY IS NOT USED AS A STANDALONE TEST. SIGNIFICANT CHANGES IN REACTIVITY ARE VERIFIED BY AN ALTERNATE ASSAY. REVIEW OF FINAL PRODUCT QUALITY CONTROL (FPQC) TESTING WAS PERFORMED, PRODUCT SPECIFICATIONS WERE MET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7736238 ↗
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 HLA-B eRES SSO Typing Kit for use with Luminex 628917Immucor 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.
How reports and recalls are matched · Editorial policy · Report an error on this page