Elecsys Tacrolimus 05889057160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630947102), received between Feb 22, 2023 and Oct 2, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S WHOLE BLOOD SAMPLES TESTED WITH ELECSYS TACROLIMUS ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023: INITIAL RESULT: >30 NG/ML. 1ST REPEAT RESULT: 9.1 NG/ML. 2ND REPEAT RESULT: 10.2 NG/ML (TESTED ON A DIFFERENT E411). 3RD REPEAT RESULT: 9.7 NG/ML (TESTED ON A DIFFERENT E411). ON (B)(6) 2023: INITIAL RESULT: 9.4 NG/ML. 1ST REPEAT RESULT: 5.6 NG/ML (NEW TREATED SAMPLE). 2ND REPEAT RESULT: 6.1 NG/ML (TESTED ON A DIFFERENT E411). THE CUSTOMER NOTICED THAT THE RESULTS DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED. ALL THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE REPEAT RESULTS OF 9.1 NG/ML AND 5.6 NG/ML WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850332 ↗
• MalfunctionJul 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TACROLIMUS ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THEY HAVE AN ONGOING ISSUE WITH THE TACROLIMUS ASSAY. THEY ARE RUNNING THE PATIENT SAMPLES ON BOTH OF THEIR E 411 ANALYZERS. PLEASE REFER TO THE ATTACHMENT PT-83173 IN THE MEDWATCH FOR THE TABLE CONTAINING EXAMPLES OF QUESTIONABLE RESULTS AND THE RESULTS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363151 ↗
• MalfunctionFeb 22, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TACROLIMUS ASSAY ON COBAS E 411 ANALYZERS (RACK SYSTEM). THE SAMPLE WAS INITIALLY TESTED ON COBAS E 411, SERIAL NUMBER: (B)(4), AND RESULTED IN A TACROLIMUS VALUE OF 30 NG/ML, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON COBAS E 411, SERIAL NUMBER: (B)(4), AND RESULTED IN A TACROLIMUS VALUE OF 10.89NG/ML. IT IS UNKNOWN WHICH RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420595 ↗