LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex 628913Recalls & 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 10888234400011), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2020No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
A COMPLAINT ((B)(4)) WAS RECEIVED ON NOVEMBER 17, 2020 FROM A CUSTOMER IN FRANCE DESCRIBING THAT LIFECODES HLA-A ERES SSO TYPING WITH LOT 3008199 AND IMGT 3.39 RESULTED IN TYPING A*03:01, A*68:02. THE LAB ALSO TESTED WITH AN ALTERNATE VENDOR PRODUCT; NGS (OMIXON) WITH A RESULT OF A*03:01,A*68:187. PER LIFECODES HLA-A ERES SSO TYPING RESULTS, THE A*68:187 AS OBTAINED WITH THE NGS METHOD IS NOT PRESENT. SAMPLE ID: (B)(6). LOT #: 3008199. CATALOG #: 628913. CUSTOMER HAS BEEN REQUESTED TO PROVIDE DNA SAMPLE TO ALLOW TESTING TO CONFIRM OR NEGATE THE COMPLAINT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11022134 ↗
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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