LIFECODES HLA-A ERES SSO TYPING KIT
Received Dec 16, 2020 · Event occurred Sep 19, 2020
Report 2183608-2020-00002 · MDR key 11022134
Device
Generic name
Qualitative Test For Hla, Non-diagnostic
Manufacturer
Immucor Gti Diagnostics, Inc.Model number
628913Catalog number
628913
Lot number
3008199
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
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.
Description of Event or Problem
THE ROOT CAUSE OF THE MISTYPING WAS A LIMITATION OF THE ASSAY FOR RARE AMBIGUITIES. IMMUCOR GTI DIAGNOTICS INC. MAKES NO CLAIMS THAT OUR TESTS ARE COMPARABLE TO NEXT-GENERATION SEQUENCING (NGS). IN ADDITION THE FOLLOWING DESCRIPTION IS INCLUDED IN THE IFU (LC1436IVDEN REV. K): "RESULTS FROM THESE KITS ARE NOT TO BE USED AS THE SOLE BASIS UPON WHICH A CLINICAL DECISION AFFECTING THE PATIENT IS MADE."
Remedial action
- Other
- Notification