Alinity 09P4220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380740154516), received between Mar 1, 2024 and Jun 19, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 19, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TACROLIMUS RESULTS FOR A 57-YEAR-OLD MALE BILATERAL LUNG TRANSPLANT PATIENT. THE PATIENT¿S RESULTS FROM (B)(6) 2025 UNTIL (B)(6) 2025 RANGED FROM 4.5 TO 22.5 UG/L. ON (B)(6) 2025, THE RESULT WAS >60 UG/L AND THE PATIENT¿S TACROLIMUS THERAPY WAS DISCONTINUED FOR FIVE DAYS. ON (B)(6) 2025, RESULT WAS 58.2, ON (B)(6) THE RESULT WAS 46.4, ON (B)(6) THE RESULT WAS 32.0, AND ON (B)(6) THE RESULT WAS 29.8 UG/L. ON (B)(6) 2025 THE RESULT WAS 53.8 UG/L, AND THE SAMPLE WAS ALSO TESTED AT A DIFFERENT LABORATORY, USING A DIFFERENT METHOD, AND THE RESULT WAS <0.6 UG/L. THE PATIENT WAS THEN PRESCRIBED TACROLIMUS AGAIN. ON (B)(6), THE RESULT WAS 18.8, REPEAT RESULT, TESTED ON ANOTHER METHOD, WAS 14.2 UG/L. ON (B)(6), THE RESULT WAS 26.1, REPEAT RESULT, TESTED ON ANOTHER METHOD, WAS 18.3 UG/L. IT WAS NOTED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE DISCONTINUANCE OF THE TACROLIMUS THERAPY. THERE WAS NO OTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293871 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I TACROLIMUS RESULTS FOR A PATIENT WITH THE DATE OF BIRTH (B)(6) 2007. THE FOLLOWING RESULTS WERE PROVIDED: THE RESULTS WERE PROVIDED INCLUDED MULTIPLE SIDS FOR THE SAME PATIENT. (CUSTOMER PROVIDED TACROLIMUS REFERENCE RANGE 5-15 NG/ML) ON (B)(6) 2024, SID (B)(6) RESULT = <2.0 NG/ML. ON (B)(6) 2024 RESULT = 13.2 NG/ML, ON (B)(6) 2024 RESULT = 18.5 NG/ML, ON (B)(6) 2024 RESULT = 44.2 NG/ML, ON (B)(6) 2024 RESULT = 15.4 NG/ML, ON (B)(6) 2024 RESULT = 13.7 NG/ML, ON (B)(6)2024 RESULT = 2.9 NG/ML, ON (B)(6)2024 RESULT = 11.2 NG/ML, ON (B)(6) 2024 RESULT = 16.5 NG/ML, ON (B)(6) 2024 RESULT = 29.7 NG/ML, ON (B)(6) 2024 RESULT = 7.4 NG/ML, ON (B)(6) 2024 RESULT = 14.3 NG/ML, ON (B)(6) 2024 RESULT = 12.4 NG/ML, ON (B)(6) 2024 RESULT = 5.1 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = <2 NG/ML, ON (B)(6) 2024 RESULT = 5.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923553 ↗
• InjuryMay 10, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TACROLIMUS FOR A 60-YEAR-OLD FEMALE THAT RECEIVED A STEM CELL TRANSPLANT ON (B)(6). THE CUSTOMER HAS SENT OUT SAMPLES IN QUESTION TO OTHER LABORATORIES WHO REPEATED WITH DIFFERENT METHOD OR PLATFORM. THE CUSTOMER PROVIDED THE FOLLOWING DATA: PATIENT RECEIVED A 1 MG DOSE OF TACROLIMUS ON (B)(6). PATIENT WAS SCHEDULED TO RECEIVE A DOSE ON (B)(6) IN THE MORNING AND IT WAS HELD DUE TO THE ELEVATED RESULT (22.6). PATIENT DID NOT RECEIVE ANOTHER DOSE (0.5 MG) UNTIL (B)(6) AT 20:30. THE CUSTOMER WAS NOT AWARE OF ANY HARM TO THE PATIENT. PATIENT NORMAL DOSING IS 2X/DAY. CUSTOMER REFERENCE RANGE 5-15 NG/ML; TOXIC RANGE IS >22 NG/ML; CRITICAL RANGE IS >30 NG/ML ON (B)(6) 2024 THE ALINITY RESULT WAS 12.2 ON (B)(6) 2024 THE ALINITY RESULT WAS 27 ON (B)(6) 2024 THE ALINITY RESULT WAS 22.6 AND THE COMPARISON TEST AT ANOTHER LABORATORY WAS 13.9. ON (B)(6) 2024 THE ALINITY RESULT WAS 16.3 ON (B)(6) 2024 THE ALINITY RESULT WAS 14.2 AND THE COMPARISON TEST AT ANOTHER LABORATORY WAS 7.2. ON (B)(6) 2024 THE ALINITY RESULT WAS 6.3 AND THE COMPARISON TEST AT ANOTHER LABORATORY WAS 4.1 ON (B)(6) 2024 THE ALINITY RESULT WAS 7.1 AND THE COMPARISON TEST AT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287257 ↗
• InjuryMar 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TACROLIMUS RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE RESULT WAS RELEASED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED: PATIENT 3: SID (B)(6) FIRST RESULT = 7.0 NG/ML. SID (B)(6) SECOND RESULT = 3.1 NG/ML. THE CUSTOMER STATED THAT DUE TO THE FALSELY ELEVATED ALINITY I TACROLIMUS RESULT, UNNECESSARY BIOPSY WAS PERFORMED ON THE PATIENT. ADDITIONAL INFORMATION REGARDING THE BIOPSY WAS REQUESTED; HOWEVER, TO DATE, IT HAS NOT BEEN PROVIDED AND/OR RECEIVED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18817824 ↗
• InjuryMar 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TACROLIMUS RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE RESULT WAS RELEASED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2: ON (B)(6) 2024, SID (B)(6) , RESULT = 18.3 NG/ML. ON (B)(6) 2024 ,SID (B)(6) , RESULT = 9.1 NG/ML. THE CUSTOMER STATED THAT DUE TO THE FALSELY ELEVATED ALINITY I TACROLIMUS RESULT, UNNECESSARY BIOPSY WAS PERFORMED ON THE PATIENT. ADDITIONAL INFORMATION REGARDING THE BIOPSY WAS REQUESTED; HOWEVER, TO DATE, IT HAS NOT BEEN PROVIDED AND/OR RECEIVED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18817798 ↗
• InjuryMar 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TACROLIMUS RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE RESULT WAS RELEASED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: ON (B)(6) 2024, SID (B)(6) FIRST RESULT = 7.1 NG/ML. ON (B)(6) 2024, SID (B)(6) SECOND RESULT = 12 NG/ML. THE CUSTOMER STATED THAT DUE TO THE FALSELY ELEVATED ALINITY I TACROLIMUS RESULT, UNNECESSARY BIOPSY WAS PERFORMED ON THE PATIENT. ADDITIONAL INFORMATION REGARDING THE BIOPSY WAS REQUESTED; HOWEVER, TO DATE, IT HAS NOT BEEN PROVIDED AND/OR RECEIVED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18817743 ↗