ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
Received Apr 3, 2026 · Event occurred Mar 12, 2026
Report 1823260-2026-01268 · MDR key 24778368
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Roche DiagnosticsCatalog number
ASKU
Lot number
ASKU
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL AST RESULT WAS 103.5 U/L, AND THE REPEATED RESULT WAS 16.4 U/L. THE INITIAL ALT RESULT WAS 68.5 U/L, AND THE REPEATED RESULT WAS 14.2 U/L. THIS MEDWATCH WILL APPLY TO THE ALANINE AMINOTRANSFERASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ASPARTATE AMINOTRANSFERASE ASSAY.