LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex 628936Recalls & 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 10888234400479), received between May 24, 2018 and May 24, 2018 — classified as 1 malfunction.
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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionMay 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
12/16/2020 AC. NOTIFICATION FROM FDA WAS RECEIVED ON NOVEMBER 27, 2020 NOTIFYING IMMUCOR GTI DIAGNOSTICS THAT THIS FOLLOW UP REPORT WAS NOT RECEIVED WHEREAS FOLLOW UP 2 REPORT WAS. SUBMISSION OF THIS REPORT IS BEING PROVIDED PER DIRECTION RECEIVED. 07-21-2017 FOLLOW-UP-REPORT TO REMOVE ONE OF THE PRODUCT CODES THAT WAS NOT APPLICABLE TO THIS NOTIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 7542137 ↗
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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