ASPARTATE AMINO TRANSFERASE
Received May 6, 2026 · Event occurred Apr 15, 2026
Report 1823260-2026-01777 · MDR key 25098725
Device
Generic name
Nadh Oxidation/nad Reduction, Ast/sgot
Manufacturer
Roche DiagnosticsCatalog number
09685383190
Lot number
918220
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ASPARTATE AMINO TRANSFERASE ASSAY ON A COBAS C 303 ANALYTICAL UNIT. INITIAL RESULT: 52.7 IU/ML. 1ST REPEAT RESULT: 35 IU/ML (TESTED ON A COBAS C 311). 2ND REPEAT RESULT: 35 U/L (TESTED ON BECKMAN).
Additional Manufacturer Narrative
THE ASPARTATE AMINO TRANSFERASE REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS C 303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE PROVIDED DATA WAS REVIEWED AND REVEALED THE FOLLOWING: - A HIGH NUMBER OF ABNORMAL ASPIRATIONS WAS OBSERVED ON (B)(6) 2026. THE C 303 ANALYTICAL UNIT MAIN WATER PRESSURE EXCEEDED THE SPECIFIED RANGE. THE CELL BLANK VALUES CONSISTENTLY EXCEEDED THE EXPECTED LIMITS EVERY DAY, EVEN IMMEDIATELY AFTER A NEW CELL EXCHANGE. THE INVESTIGATION IS ONGOING.