ARCHITECT 8K25-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740048471), received between Dec 12, 2016 and Apr 26, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A PROVIDER QUESTIONED FALSELY ELEVATED ARCHITECT INTACT PTH RESULTS (CONFIRMED BY REPEAT AND THEN BY RECOLLECTION) THAT CONFLICTED WITH A HIGH NORMAL VALUE OBTAINED BY THE PATIENT AT LABCORP AT ABOUT THE SAME TIME. THE INITIAL ARCHITECT INTACT PTH RESULT FROM (B)(6) 2021 WAS SID (B)(4) 106.1 PG/ML (CURRENT REFERENCE RANGE: 15.0 PG/ML TO 73.5 PG/ML); QUEST: 54 PG/ML (QUEST REFERENCE RANGE: 14 PG/ML TO 64 PG/ML); LABCORP: 61 PG/ML (LABCORP REFERENCE RANGE: 15 PG/ML TO 65 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726826 ↗
• MalfunctionAug 5, 2020High Test Results; High Test Results

  ADDITIONAL PATIENT DATA PROVIDED ON (B)(6) 2020: SAMPLE ID (B)(6) I1000SR RESULT WAS 127.6 PG/ML, RESULT ON THE COBAS WAS 55 PG/ML SAMPLE ID (B)(6) I1000SR RESULT WAS 59.9 PG/ML, RESULT ON THE COBAS WAS 35 PG/ML SAMPLE ID (B)(6) I1000SR RESULT WAS 134.3 PG/ML, RESULT ON THE COBAS WAS 72 PG/ML SAMPLE ID (B)(6) I1000SR RESULT WAS 69.0 PG/ML, RESULT ON THE COBAS WAS 38 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370550 ↗
• MalfunctionMay 8, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT INTACT PTH OF 96.9 PG/ML (REFERENCE RANGE 8.5 TO 72.5 PG/ML) ON A PATIENT SID (B)(6) WHO TESTED ROCHE METHOD OF 61.3 PG/ML (REFERENCE RANGE 15 TO 65 PG/ML) AND BECKMAN METHOD OF 72 PG/ML (REFERENCE RANGE 12 TO 88 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040808 ↗
• MalfunctionNov 27, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT INTACT PTH (IPTH) RESULT OF >3000 PG/ML WAS GENERATED FOR A (B)(6) YEAR OLD FEMALE PATIENT ON (B)(6) 2018. THE RESULT WAS REPORTED BY THE TECHNICIAN WITHOUT RETESTING TO CONFIRM THE ELEVATED RESULT. THE RESULT WAS QUESTIONED BY THE CLINICIAN BECAUSE IT DID NOT MATCH THE CLINICAL PICTURE. THE PATIENT WAS REDRAWN ON (B)(6) 2018 AND THE ARCHITECT INTACT PTH RESULT WAS 74.8 PG/ML. THE SAMPLE FROM (B)(6) 2018 WAS THEN RETESTED GENERATING A RESULT OF 73.4 PG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105886 ↗
• MalfunctionNov 12, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT INTACT PTH RESULTS FOR MULTIPLE PATIENT SAMPLES WHEN COMPARED TO AN ALTERNATE METHOD. PATIENT 1: 131 PG/ML ON ARCHITECT AND 39 PG/ML ON ALTERNATE METHOD. PATIENT 2: 146 PG/ML ON ARCHITECT AND 58 PG/ML ON ALTERNATE METHOD. PATIENT 3: 287 PG/ML ON ARCHITECT AND 113 PG/ML ON ALTERNATE METHOD. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059959 ↗
• MalfunctionJun 25, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PARATHYROID HORMONE(IPTH) RESULTS WHILE USING THE ARCHITECT IPTH ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER INDICATED THAT THE PHYSICIAN QUESTIONED THE INCREASE IN RESULT. THE CUSTOMER INDICATED THEY HAVE A PATIENT WHO GENERATED A RESULT OF 300 A FEW MONTHS AGO (NO SPECIFIC DATE PROVIDED OR UNIT OF MEASURE) USING THE ROCHE METHOD. A RESULT OF 600 WAS GENERATED RECENTLY USING THE ARCHITECT ASSAY. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635584 ↗
• MalfunctionJun 6, 2018Incorrect Or Inadequate Test Results; High Test Results; Incorrect Or Inadequate Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS WHILE USING ARCHITECT INTACT PTH REAGENTS. THE PATIENTS ARE DIALYSIS PATIENTS AND ARE TESTED MONTHLY. THE FOLLOWING DATA WAS PROVIDED. (B)(6) (TESTED (B)(6) 2018) 496 PG/ML. PREVIOUS RESULT ((B)(6) TESTED (B)(6) 2018) WAS LOWER, 346 PG/ML. THE PATIENT WAS GIVEN MEDICATION, HECTOROL (2 MCG IV) DUE TO THE FALSELY ELEVATED MAY RESULT. (B)(6) (TESTED (B)(6) 2018) 486 PG/ML. PREVIOUS RESULT ((B)(6) TESTED (B)(6) 2018) WAS LOWER, 182 PG/ML. HECTOROL IV MEDICATION FOR THE PATIENT WAS INCREASED FROM 5 MCG TO 6 MCG DUE TO THE FALSELY ELEVATED MAY RESULT. NO ADVERSE IMPACT TO PATIENTS WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574460 ↗
• MalfunctionMay 16, 2017High Test Results; High Test Results

  THE ACCOUNT GENERATED (B)(6) ARCHITECT INTACT PTH RESULTS FOR 5 PATIENT SAMPLES IN (B)(6) 2016. (B)(6). NO UNIT OF MEASURE OR SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568711 ↗
• MalfunctionMay 12, 2017False Positive Result; False Positive Result

  THE CUSTOMER EXPRESSED CONCERN REGARDING ARCHITECT INTACT PTH (IPTH) RESULTS BEING ELEVATED WHEN COMPARED TO ANOTHER LABORATORY WHICH RECOVERED NORMAL VALUES FOR THE SAME PATIENT SAMPLES. ARCHITECT IPTH VALUES OF 112.1, 123.4, 117.2, 100.4 AND 147.7 PG/ML WERE GENERATED FOR SAMPLES THAT TESTED AT 61, 30, 42, 32 AND 39 PG/ML RESPECTIVELY USING AN ELECTROCHEMILUMINESCENT METHOD AT ANOTHER LABORATORY. THE FIVE PATIENTS HAVE NORMAL CALCIUM, CREATININE AND VITAMIN D VALUES. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6564545 ↗
• MalfunctionMay 9, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED IPTH RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: ARCHITECT = 95, ON ANOTHER UNKNOWN METHOD AT THE HOSPITAL = 67 (42% SHIFT). THE PATIENT WAS SCHEDULED FOR AN UNNECESSARY PARATHYROIDECTOMY BASED ON THE ARCHITECT RESULTS, BUT THE PROCEDURE WAS CANCELLED UPON THE REPEAT RESULT AT THE HOSPITAL. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6556071 ↗
• MalfunctionApr 13, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED IPTH RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 34 PG/ML, REPEAT 33PG/ML. THE PATIENT HAS PREVIOUS RESULTS OF 58PG/ML, WHICH IS A 43% SHIFT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6492343 ↗
• MalfunctionDec 12, 2016High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT IPTH RESULTS WERE GENERATED ON 2 SAMPLES. SAMPLE 1: AN INITIAL RESULT OF 85.7 PG/ML WAS GENERATED. THE RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE SAMPLE WAS SENT TO ANOTHER LAB WHICH GENERATED A RESULT OF 55 PG/ML. A PREVIOUS RESULT FOR THE PATIENT WAS 110 PG/ML BUT THAT SAMPLE WAS NOT SENT OUT FOR FURTHER TESTING. SAMPLE 2: AN INITIAL RESULT OF 68 PG/ML WAS GENERATED. THE SAMPLE WAS SENT TO ANOTHER LAB WHICH GENERATED A RESULT OF 49 PG/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6167703 ↗