ELECSYS TACROLIMUS
Received Feb 25, 2026 · Event occurred Jan 29, 2026
Report 1823260-2026-00691 · MDR key 24444919
Device
Generic name
Tacrolimus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07251254190
Lot number
834814
Product problems
- Incorrect Measurement
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT, COMPARED TO MASS SPECTROMETRY RESULTS. THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLES. NO UNITS OF MEASURE WERE PROVIDED. ON (B)(6) 2026, SAMPLE 1 HAD A RESULT OF 6.57. THE MASS SPECTROMETRY RESULT WAS 6.40. ON (B)(6) 2026, SAMPLE 2 HAD A RESULT OF 6.57. THE MASS SPECTROMETRY RESULT WAS 8.90. ON (B)(6) 2026, SAMPLE 3 HAD A RESULT OF 5.46. THE MASS SPECTROMETRY RESULT WAS 7.1. ON (B)(6) 2026, SAMPLE 4 HAD A RESULT OF 10.9. THE MASS SPECTROMETRY RESULT WAS 12.7.