Elecsys Tacrolimus 07251254190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630940271), received between Jan 5, 2023 and Sep 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570988 ↗
• MalfunctionDec 19, 2025Incorrect, 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

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850301 ↗
• MalfunctionDec 11, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT COLLECTED FROM A MEDICATION LINE THAT THE PATIENT RECEIVES PARENTERAL NUTRITION WAS 32.5 NG/ML WITH A MASS SPECTROMETRY ANALYZER. THE RESULT WITH THE E801 WAS 23 NG/ML. A SECOND RESULT AFTER A DILUTION OF 1:2 WAS 11.7 NG/ML. ANOTHER SAMPLE WAS COLLECTED FROM THE DIALYSIS CATHETER WITH THE FOLLOWING RESULTS. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 5.8 NG/ML. THE RESULT WITH THE E801 WAS 6.23 NG/ML. ON (B)(6) 2025, A SAMPLE WAS COLLECTED FROM THE DIALYSIS CATHETER. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 6.7 NG/ML. THE RESULT WITH THE E801 WAS 6.14 NG/ML. ON (B)(6) 2025, A SAMPLE WAS COLLECTED FROM THE MEDICATION LINE WITHOUT PARENTERAL NUTRITION. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 23.9 NG/ML. THE RESULT WITH THE E801 WAS 16.3 NG/ML. PATIENT 2'S INITIAL RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 3.4 NG/ML. THE RESULT WITH THE E801 WAS 4.65 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778185 ↗
• MalfunctionFeb 4, 2025Low Test Results; Output Problem; Non Reproducible Results; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.5 NG/ML WITH A DATA FLAG. ON (B)(6) 2025, THE REPEAT RESULT WAS 10.1 NG/ML. ON (B)(6) 2025, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS 13.0 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307380 ↗
• MalfunctionApr 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL RESULT WAS <0.500 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS <0.500 NG/ML WITH A DATA FLAG. ON (B)(6) 2024, THE SAMPLE WAS REPEATED WITH A RESULT OF 0.502 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119362 ↗
• MalfunctionJan 5, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW TACROLIMUS ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.52 NG/ML AND THE REPEAT RESULT ON (B)(6) 2022 WAS 8.31 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 58612101 WITH AN EXPIRATION DATE OF 30-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103467 ↗