LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine 628923Recalls & reported problems
Immucor Gti Diagnostics, Inc. · DNA Typing of Class II 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 10888234400066), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
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.
MalfunctionJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018 CUSTOMER CALLED IN WITH COMPLAINT NUMBER (B)(4) TO REPORT FAILURE FOR PROBES 007 AND 008 FOR SAMPLES TESTED WITH LIFECODES HLA-DRB1 SSO TYPING KIT. THEY REPORT THAT IN A SINGLE BATCH OF 48 SAMPLES TESTED WITH DR1 SSO TYPING KIT (LOT #04226A) PROBES 007 AND 008 WERE NEGATIVE FOR ALL SAMPLES. TECH SUPPORT HAS CONTACTED THE DISTRIBUTOR SEVERAL TIMES AS OF TODAY WITH NO RESPONSE SINCE JUNE 1 WHEN COMPLAINT WAS MADE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7650576 ↗
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-B eRES SSO Typing Kit for use with Luminex 628917Immucor 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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