ELECSYS TACROLIMUS
Received Dec 19, 2025 · Event occurred Dec 1, 2025
Report 1823260-2025-05233 · MDR key 23850301
Device
Generic name
Tacrolimus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07251254190
Lot number
83481400
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MEASURING CELL WAS EXCHANGED ON (B)(6) 2025. A GENERAL REAGENT ISSUE CAN BE EXCLUDED SINCE THE QC WAS WITHIN THE RANGES ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER PERFORMED A LIQUID FLOW CLEANING. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A NON-OPTIMAL CUSTOMER INSTRUMENT MAINTENANCE.
Additional Manufacturer Narrative
THE TACROLIMUS REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6) THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 6 PATIENTS' SAMPLES TESTED WITH ELECSYS TACROLIMUS ASSAY ON A COBAS E 801 MODULE. SAMPLE 1: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 11.3 UG/L. SAMPLE 2: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 10.7 UG/L. SAMPLE 3: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 10.1 UG/L. SAMPLE 4: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 11.6 UG/L. SAMPLE 5: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 12.8 UG/L. SAMPLE 6: INITIAL RESULT: >40 UG/L. REPEAT RESULT: 15.7 UG/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AND REQUESTED THAT THE SAMPLES BE REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.