ARCHITECT 7K72-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380740014711), received between Jun 17, 2019 and May 1, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT ESTRADIOL. THE CUSTOMER REPORTED THAT THEY WERE EXPECTING HIGH ESTRADIOL ON THE ARCHITECT PLATFORM, WHICH GENERATED LOWER RESULTS WHEN COMPARED WITH ANOTHER ANALYZER PLATFORM (PLATFORM UNKNOWN). THE PATIENT DOCTOR QUESTIONED THE RESULT BASED UPON THE TREATMENT THE PATIENTS ARE GETTING AT THE FERTILITY TREATMENT, PRIMOGYN. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SAMPLE (B)(6), RESULT WAS 491.7 AND RESULT FROM A REFERENCE LAB WAS 1036.40. PATIENT IS 42-YEAR-OLD FEMALE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL DATA: THE CUSTOMER CLARIFIED THAT BEFORE STARTING FERTILITY TREATMENTS WITH PRIMOGYN THE ESTRADIOL WAS IN NORMAL RANGE (NORMAL RANGE NOT PROVIDED). THE CUSTOMER STATES THAT ADDITIONAL ANALYZER PLATFORM WAS THE VITROS INSTRUMENT (AMPLIFIED CHEMILUMINESCENCE) WITH UNIT OF MEASURE PG/ML. THE CUSTOMER REPORTED THAT THE RESULTS FROM THE VITROS WERE THE MORE ACCURATE RESULTS. THE CUSTOMER PROVIDED UPDATED INFORMATION FOR SAMPLE (B)(6): THE REFERENCE LAB RESULT FOR ESTRADIOL WAS 2290.4 PG/ML AND THAT THE PATIENT'S AGE IS 34 YEARS OLD. THE CUSTOMER ALSO REPORTED A PROGESTERONE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946018 ↗
• MalfunctionMay 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY A DECREASED ARCHITECT ESTRADIOL RESULT ON A 32-YR OLD FEMALE PATIENT THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 ARCHITECT = 434 PG/ML; ANOTHER LABORATORY (ELECTROCHEMILUMINESCENCE) = 520 PG/ML; ANOTHER LABORATORY (CHEMILUMINESCENCE) = 384 PG/ML; ANOTHER LABORATORY = 1029.30 PG/ML. ADDITIONAL PATIENT ADDED ON (B)(6) 2025: (B)(6) 2025 (32-YR OLD FEMALE) = SID (B)(6) = 434 PG/ML; ANOTHER LABORATORY = 384.00 PG/ML; ANOTHER LABORATORY = 1029.3 PG/ML; ANOTHER LABORATORY = 520.0 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941035 ↗
• InjuryOct 10, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT ESTRADIOL RESULTS ON A 42-YEAR-OLD FEMALE PATIENT THAT RESULTED IN A BILATERAL OOPHORECTOMY IN (B)(6) 2023. THE PATIENT BEGAN TAKING ABEMACICLIB FOR THE TREATMENT OF RIGHT BREAST CANCER T2N1 BEGINNING IN (B)(6) 2022. ADDITIONALLY, THE PATIENT ALSO CONCOMITANTLY TOOK ADJUVANT ENDOCRINE THERAPY. IN (B)(6) 2023 THE PATIENT¿S ARCHITECT ESTRADIOL RESULTS WERE 336 PMOL/L. THE PHYSICIAN SWITCHED THE PATIENT¿S ADJUVANT ENDOCRINE THERAPY, HOWEVER, THE ESTRADIOL RESULTS REMAINED ELEVATED. DUE TO THE INADEQUATE OVARIAN SUPPRESSION, THE PATIENT UNDERWENT A BILATERAL OOPHORECTOMY IN (B)(6) 2023. AFTER THE SURGERY, THE PATIENT¿S ESTRADIOL RESULTS REMAINED ELEVATED AT 330 PMOL/L. IN (B)(6) 2024, THE ARCHITECT ESTRADIOL RESULT WAS 500 PMOL/L. THE PATIENT¿S ENDOCRINOLOGIST HAD HER ESTRADIOL LEVELS TESTED AT DIFFERENT HOSPITALS WITH DIFFERENT PLATFORMS (ROCHE, SIEMENS, BECKMAN) AND THEY ALL GENERATED THE SAME RESULT OF <60 (UNKNOWN UNIT OF MEASURE). NO ADDITIONAL/FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415693 ↗
• MalfunctionMar 14, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT ESTRADIOL RESULTS, WHICH QUESTIONED BY PHYSICIAN ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) (B)(6) YEAR OLD FEMALE: INITIAL ESTRADIOL ALIQUOT= (B)(6) PG/ML /REPEATED=(B)(6) PG/ML /REPEATED AFTER RE-SPUN=(B)(6) PG/ML /REPEATED ORIGINAL TUBE= (B)(6) PG/ML ON (B)(6) 2022 SID (B)(6) (B)(6) YEAR OLD FEMALE: INITIAL ESTRADIOL ALIQUOT = 415 PG/ML/ REPEATED AFTER RE-SPUN = 6013 PG/ML /REPEATED ORIGINAL TUBE= 5926 PG/ML LABORATORY ESTRADIOL REFERENCE RANGE: FOLLICULAR PHASE: 21-251; MID-CYCLE PHASE: 38-649; LUTEAL PHASE: 21-312; POSTMENOPAUSAL: NO HORMONE REPLACEMENT THERAPY: <10-28; HORMONE REPLACEMENT THERAPY: <10-144 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760847 ↗
• MalfunctionJan 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT ESTRADIOL RESULT FOR A PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT SID (B)(6) GENERATED AN INITIAL RESULT OF > 1000 PG/ML ON THE ARCHITECT ANALYZER. THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF 3422 PG/ML, WHILE THE RESULTS FROM OTHER PLATFORMS GENERATED RESULTS THAT WERE LESS THAN THE REFERENCE RANGE. THE PATIENT WAS DIAGNOSED WITH ENDOMETRIOSIS AND STARTED ON MIFEPRISTONE FOR 1 MONTH. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11200902 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE DECREASED ARCHITECT ESTRADIOL RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2021 SID 210040034 = INITIAL RESULT = 235 PG/ML. ON (B)(6) 2021 SID 210040034 = REPEAT RESULT = >1000 PG/ML; REPEAT RESULT (1:10 MANUAL DILUTION) = 2085 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11187909 ↗
• MalfunctionDec 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ACCOUNT OBSERVED FALSE ELEVATED ARCHITECT ESTRADIOL RESULTS OF >1000 PG/ML ON (B)(6) 2020 ON A (B)(6) YEAR OLD FEMALE PATIENT WHO RECENTLY HAD A HYSTEROSCOPY. THE PATIENT WAS TESTED AGAIN ON (B)(6) 2020 WITH ARCHITECT ESTRADIOL OF 87 PG/ML. THE ACCOUNT USES A REFERENCE RANGE OF FEMALE: FOLLICULAR PHASE 21-251 PG/ML OVULATION PHASE 38-649 PG/ML, LUTEAL PHASE 21-312 PG/ML POSTMENOPAUSAL = 28 PG/ML. THE PATIENT WAS TAKING MIFEPRISTONE AROUND (B)(6) 2020. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10990994 ↗
• MalfunctionAug 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT ESTRADIOL RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT A: (B)(6) FEMALE PATIENT WITH ECTOPIC PREGNANCY, (B)(6) 2020 INITIAL RESULT = 234 PG/ML, TESTED AGAIN AFTER MIFEPRISTONE TREATMENT WAS >1000 PG/ML, REPEAT >1000 PG/ML, REPEAT AT ANOTHER HOSPITAL WAS 200 PG/ML. PATIENT B: PREGNANT FEMALE, (B)(6) 2020 INITIAL RESULT = 89 PG/ML, TESTED AGAIN AFTER MIFEPRISTONE TREATMENT WAS >1000 PG/ML, REPEAT AT ANOTHER HOSPITAL WITH ROCHE = 46 (UNITS OF MEASURE NOT PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10414318 ↗
• MalfunctionAug 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT ESTRADIOL ASSAY RESULTS WERE GENERATED FOR ONE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: (B)(6) 2020 INITIAL = 122 PG/ML, REPEAT = 233 PG/ML; (B)(6) 2020 INITIAL = 1000 PG/ML. THE SAMPLE FROM (B)(6) 2020 WAS RETESTED AND THE RESULT WAS STILL >1000 PG/ML. THE CUSTOMER STATED THAT THE PATIENT HAD A MISCARRIAGE AND CONSIDERING THE POSTPARTUM MEDICATIONS THAT ARE ADMINISTERED, THEY THOUGHT THE MEDICATIONS COULD HAVE INTERFERED WITH THE ESTRADIOL RESULTS. NO SPECIFIC INFORMATION REGARDING POSTPARTUM MEDICATIONS WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THIS EVENT IS BEING REPORTED CONSERVATIVELY AS NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10374941 ↗
• MalfunctionJan 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT ESTRADIOL RESULT FOR A (B)(6) FEMALE PATIENT FOLLOWING A MISCARRIAGE. ON (B)(6) 2020 THE PATIENT SAMPLE GENERATED RESULTS OF 33 PMOL/L ON THE ARCHITECT, 81 PMOL/L ON MINDRAY AND 443.9 PMOL/L ON THE ROCHE ASSAY. A NEW SAMPLE WAS COLLECTED ON (B)(6) AND GENERATED AN ELEVATED RESULT ON ARCHITECT OF 1268 PMOL/L AND LOWER RESULTS ON MIDRAY 70 PMOL/L AND ROCHE 308.5 PMOL/L. THERE WASNO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641733 ↗
• MalfunctionOct 8, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT ESTRADIOL RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = >5000 PG/ML WITH A 1:5 DILUTION / THE SAMPLE WAS SENT OUT FOR CONFIRMATION ON A ROCHE METHOD = 65 PG/ML. A NEW SAMPLE WAS COLLECTED AND GENERATED >5000 PG/ML ON THE ARCHITECT. THE CUSTOMER FURTHER INDICATED SID (B)(4) ON (B)(6)2019 = 1641 PG/ML FOR ESTRADIOL; TESTOSTERONE = 114 NG/ML (NORMAL RANGE FOR THIS PATIENT 8-48NG/DL); AND FREE TESTOSTERONE = 24.2 NG/ML. THE PATIENT IS ON MIFERISTONE AND THE CUSTOMER IS INQUIRING ABOUT DRUG INTERFERENCE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9167641 ↗
• MalfunctionSep 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT ESTRADIOL RESULT ON ONE (B)(6) YEAR OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(6) = 794 PG/ML(REFERENCE RANGE: FEMALES: FOLLICULAR PHASE 21 - 251 OVULATORY PHASE 38 - 649, LUTEAL PHASE 21 - 312 POST-MENOPAUSAL </= 28). THE PATIENT WENT TO ANOTHER HOSPITAL WHERE THE ESTRADIOL RESULT ON THE ROCHE METHOD = 18 PG/ML. THE CUSTOMER SENT THE PATIENT SAMPLE TO ANOTHER HOSPITAL AND THE RESULT = 708PG/ML. THE PATIENT LODGED A COMPLAINT BECAUSE THE DISCREPANCY BETWEEN THE RESULTS WAS TOO LARGE AND THE ABBOTT PLATFORM RESULT WAS INCONSISTENT WITH THE CLINICAL DIAGNOSIS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9010570 ↗
• MalfunctionJul 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED ESTRADIOL RESULTS ON ONE (B)(6) FEMALE PATIENT. THE RESULTS PROVIDED WERE: ARCHITECT =>1000PG/ML / RETESTED = >1000PG/ML (REFERENCE RANGES: FEMALE: FOLLICULAR PHASE 21 - 251 OVULATORY PHASE 38-649; LUTEAL PHASE 21 - 312 POST-MENOPAUSAL </= 28); SAMPLE SENT AND TESTED ON ROCHE = 118.5PG/ML. THE PHYSICIAN STATED THAT THIS IS INCONSISTENT WITH THE CLINICAL SYMPTOMS. THE CUSTOMER STATED THE PATIENT HAD A RECENT HISTORY OF USING MIFEPRISTONE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8768999 ↗
• MalfunctionJun 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED ESTRADIOL RESULTS ON THREE PATIENTS. THE PHYSICIAN STATED THE ELEVATED RESULTS DID NOT MATCH CLINICAL SYMPTOMS. THE RESULTS PROVIDED WERE: PT#1 ARCHITECT = 32044PMOL/L (FOLLICULAR PHASE 77.1-921.2) / ROCHE = 412.4 (FOLLICULAR PHASE 45.5-854.0); PT#2 ARCH = 47348 (MID MENSTRUATION 139.5-2381.8) / ROCHE =233 (OVULATION PHASE 151.0-1461.0); PT#3 ARCH = 95560 (LUTEAL PHASE 77.1 -1145.00) / ROCHE = 366.8 (LUTEAL PHASE 81.9-1251.0). ALL 3 FEMALES OF CHILD BEARING AGE HAD BEEN ADMINISTERED MIFEPRISTONE WITHIN THE PAST 2 WEEKS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704560 ↗