InjuryMVM
QUANTA FLASH H-TTG IGA
Received May 19, 2017 · Event occurred Apr 17, 2017
Report MW5069924 · MDR key 6584659
Device
Generic name
Autoantibodies, Endomysial (tissue Transglutaminase
Manufacturer
Inova Diagnostics, IncLot number
1059
Product problems
- Incorrect Or Inadequate Test Results
Patient
13 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SEVERAL COMPLAINTS HAVE BEEN RECEIVED BY THE LABORATORY WHERE THE INOVA QUANTA FLASH HUMAN TISSUE TRANSGLUTAMINASE IGA TESTING DID NOT FIT THE CLINICAL PICTURE OR THERE WERE NEGATIVE RESULTS BY OTHER REFERENCE LABORATORIES. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: AID IN THE DIAGNOSIS OF THE GLUTEN SENSITIVE ENTEROPATHIES.