CREATININE JAFFE GEN.2
Received Jul 21, 2026 · Event occurred Apr 26, 2026
Report 1823260-2026-02945 · MDR key 25888758
Device
Generic name
Creatinine, Alkaline Picrate Colorimetry
Manufacturer
Roche DiagnosticsCatalog number
09686231190
Lot number
ASKU
Product problems
- High Test Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION OF QUESTIONABLE CREATININE JAFFE GEN.2 AND TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON TWO COBAS C 111 ANALYZERS (COBAS A AND COBAS B).THIS MEDWATCH IS FOR THE CREATININE JAFFE GEN.2 ASSAY ON COBAS A. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (b)(6) FOR THE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY ON COBAS B.PATIENT SAMPLE 1THE INITIAL RESULT WAS 1.5 MG/DL.THE REPEAT RESULT WAS 0.9 OR <1.0 MG/DL.
Additional Manufacturer Narrative
THE COBAS C 111 ANALYZER SERIAL NUMBER FOR COBAS A IS (b)(6).