ARCHITECT 1L77-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380740001377), received between May 26, 2017 and Apr 13, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS ON ONE KIDNEY TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE: RENAL TRANSPLANT PERFORMED ON (B)(6) AND TACROLIMUS ON (B)(6) = AROUND < 10 NG/ML. ON (B)(6) 2023 SID (B)(6) 1:1=> 30 NG/ML; 1:4=60.30 NG/ML. ON (B)(6) 2023 SID (B)(6) 1:1= >30 NG/ML; 1:2= >60 NG/ML; 1:3=77.1 NG/ML; 1:4=76.6 NG/ML. ON (B)(6) 2023 SID (B)(6) 1:1=>30 NG/ML; 1:3=39.60 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731740 ↗
• MalfunctionApr 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS ON ONE KIDNEY TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE: RENAL TRANSPLANT PERFORMED ON (B)(6) AND TACROLIMUS ON (B)(6)= AROUND < 10 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1=> 30 NG/ML; 1:4=60.30 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1= >30 NG/ML; 1:2= >60 NG/ML; 1:3=77.1 NG/ML; 1:4=76.6 NG/ML ON (B)(6) 2023 SID (B)(6) 1:1=>30 NG/ML; 1:3=39.60 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717274 ↗
• InjuryDec 12, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TACROLIMUS RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), (B)(6) 2022 RESULT 7.4 NG/ML, PHARMACY INCREASED DOSAGE BY 0.5 MG/DAY, PATIENT REDRAWN ON (B)(6) 2022 AND RESULTED AS 29.5 NG/ML (MUCH HIGHER THAN PHARMACIST WOULD HAVE EXPECTED WITH THE DOSAGE CHANGE) (LAB'S REFERENCE RANGE: 4-12 NG/ML). ASIDE FROM MEDICATION DOSAGE ADJUSTMENT, NO KNOWN IMPACT TO PATIENT CARE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15960091 ↗
• MalfunctionOct 6, 2022High Test Results; High Test Results

  A JOURNAL ARTICLE BY BAKIR, AYFER; GUNEY, MUSTAFA, ¿PAXLOVID-TACROLIMUS DRUG¿DRUG INTERACTION IN A 23-YEAR-OLD FEMALE KIDNEY TRANSPLANT PATIENT WITH COVID-19¿, CLINICAL LABORATORY 68 (8-2022). CLINICAL LABORATORY PUBLICATIONS. (AUG 2022), DOCUMENTED FALSE POSITIVE ARCHITECT TOXO IGM RESULTS. THE STUDY NOTED THAT FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS OCCURRED ON A 23-YR OLD FEMALE KIDNEY TRANSPLANT PATIENT WHO RECEIVED PAXLOVID TO TREAT A COVID-19 INFECTION. RESULTS FROM THE STUDY PROVIDED: TACROLIMUS CONCENTRATION WAS TAKEN BEFORE FIRST PAXLOVID TABLET, AFTER THE MORNING DOSE OF TACROLIMUS, AND DOES NOT REPRESENT THE TROUGH CONCENTRATION DATE (JAN 2022) TACROLIMUS DAILY DOSE (MG) PAXLOVID DOSE (MG) TACROLIMUS CONCENTRATION (NG/ML) RECOMMENDED RANGE FOR TACROLIMUS CONCENTRATION IN KIDNEY TRANSPLANT PATIENTS, UP TO 15 NG/ML BASELINE 4 8¿10 10 (ADMISSION DAY) 3 NA 11 1 300 MG/100 MG × 1/DAY 10 TACROLIMUS WAS TAKEN BEFORE 1ST PAXLOVID DOSE, AFTER THE MORNING DOSE OF TACROLIMUS, AND DOES NOT REPRESENT THE TROUGH CONCENTRATION 12 2 300 MG/100 MG × 2/DAY 13.6 13 2 48.5 14 1 92.4 15 0.5 85.8 16 (DISCHARGE) 0.5 62 17 0 NA 18 0 14.9 NA = NOT ASSESSED NO IMPACT TO PATIENT MANAGEMENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557766 ↗
• MalfunctionMay 5, 2022Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED ARCHITECT TACROLIMUS RESULTS FOR ONE PATIENT. THE PATIENT IS A 15 YEAR-OLD FEMALE, SID (B)(6) RESULT OF 2.98 PG/ML (REFERENCE RANGE: 5-20) WAS QUESTIONED BY THE PHYSICIAN AS SKEWED LOW. THE PATIENT WAS ORIGINALLY TESTED AT ANOTHER LABORATORY USING A DIFFERENT PLATFORM, WITH RESULTS ALL WITHIN THE REFERENCE RANGE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288706 ↗
• MalfunctionDec 16, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE = 2 ¿ 30 NG/ML): ON (B)(6) 2020 SID (B)(6) = INITIAL RESULT = > 30.0 NG/ML, DILUTION 1:2 RESULT = > 60.0 NG/ML, DILUTION 1:3 RESULT = > 90.0 NG/ML, DILUTION 1:4 RESULT = >120.0 NG/ML, DILUTION 1:7 RESULT = 148.2 NG/ML, DILUTION 1:10 RESULT = 154.1 NG/ML; NEW BLOOD COLLECTION OF PATIENT = RESULT = APPROX. 15 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11016890 ↗
• MalfunctionApr 22, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TACROLIMUS RESULTS FOR ONE PATIENT. RESULTS PROVIDED: INITIAL = 44NG/ML, REPEAT = 16NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9985476 ↗
• MalfunctionJun 20, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED ONE PATIENT WITH A FALSELY ELEVATED TACROLIMUS RESULT WHILE USING THE ARCHITECT TACROLIMUS ASSAY. THE FOLLOWING RESULTS WERE PROVIDED: THE FIRST SPECIMEN WAS COLLECTED BEFORE 8:00 AM: INITIAL RESULT: OVER 30 NG/ML, RETESTED AFTER DILUTION: 54 NG/ML. AFTER THE PATIENT RECEIVED TACROLIMUS A NEW SPECIMEN WAS TESTED AT 10:30 AM, GENERATING A RESULT OF 5.38 NG/ML (TROUGH VALUE). THE CUSTOMER INDICATED THAT THIS PATIENT USUALLY HAS A TROUGH VALUE OF 3-4 NG/ML. THE SPECIMEN WAS SENT TO A REFERENCE LAB AND GENERATED SIMILAR RESULTS (SPECIFIC RESULTS DATA NOT PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621698 ↗
• MalfunctionMay 26, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED ONE PATIENT WITH A FALSELY ELEVATED TACROLIMUS RESULT WHILE USING THE ARCHITECT TACROLIMUS ASSAY. THE RESULTS WERE GENERATED DURING TREATMENT FOR A PATIENT UNDERGOING ACUTE REJECTION FOR A HEART TRANSPLANT (RECEIVED (B)(6) 2016). THE CUSTOMER INDICATED THAT 2 CONSECUTIVE VALUES WHICH HAD BEEN DRAWN ON (B)(6) 2017 SHOWED A FALSELY ELEVATED, AS FOLLOWS: ON (B)(6) 2017: 11.2 MG/DL. ON (B)(6) 2017: 44.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6594247 ↗