ARCHITECT 7K72-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740106065), received between Dec 9, 2019 and Feb 16, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT ESTRADIOL RESULT FOR ONE PATIENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT PREVIOUSLY HAD AN ELEVATED ESTRADIOL RESULT OF > 2000 PG/ML WITH A RISK OF THROMBOEMBOLISM. THE SAME SAMPLE WAS REPEATED, AND THE RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 942 PG/ML (UNDILUTED). (B)(6) 2023 SID (B)(6) 1ST REPEAT RESULT = > 1000 PG/ML (UNDILUTED); DILUTION 1:5 RESULT = 3354 PG/ML. (B)(6) 2023 SID 530121101018 2ND REPEAT RESULT = > 1000 PG/ML (UNDILUTED); DILUTION 1:5 RESULT = 3729.319 PG/ML. PATIENT¿S PREVIOUS RESULT = > 2000 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ON 01MAR2023, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON THIS PATIENT. THE PATIENT IS FEMALE WHO IS HAVING AN ONGOING TREATMENT WITH FYREMADEL, MENOPUR 112, AND FOLIC ACID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384825 ↗
• MalfunctionNov 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT ESTRADIOL RESULT FOR A PATIENT HAVING AN INTRAUTERINE DEVICE REMOVED. THE PATIENT WAS NOT PREGNANT AND HAD A PROGESTERONE RESULT OF 0.32. THE PATIENT'S SAMPLE GENERATED AN ESTRADIOL RESULT OF 3670 PMOL/L ON THE ARCHITECT. THE PHYSICIAN EXPECTED THE ESTRADIOL RESULT TO BE A LOW VALUE. THE SAMPLE WAS RETESTED ON ROCHE AND GENERATED 15 PG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819566 ↗
• MalfunctionSep 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED FALSELY ELEVATED ARCHITECT ESTRADIOL RESULTS ON ONE PATIENT WITH RECURRENT MISCARRIAGES. THE CUSTOMER STATED THAT THE ARCHITECT GENERATED AN E2 RESULT OF >1000 PG/ML, COMPARED TO THE ROCHE RESULT OF 88 PG/ML. THE PATIENT HAD TAKEN MIFEPRISTONE TABLETS. THE CUSTOMER BELIEVES THE CAUSE OF THE ELEVATED RESULTS WAS DRUG INTERFERENCE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10494015 ↗
• MalfunctionDec 9, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ESTRADIOL RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 (B)(6) AFTER INTRAUTERINE SURGERY THE ESTRADIOL = 1253PG/ML (FOLLICULAR PHASE 21-251; OVULATION PHASE 38-649; LUTEAL PHASE 21-312; POSTMENOPAUSAL = </=25)/ AT A DIFFERENT HOSPITAL ON (B)(6) 2019 WITH THE BECKMAN METHOD = 22PG/ML. THE PATIENT TOOK MIFEPRISTONE TO SOFTEN HER CERVIX PRIOR TO SURGERY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439237 ↗