ARCHITECT 7K78-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00380740014971), received between Dec 15, 2016 and Jun 24, 2025 — classified as 2 injuries, 108 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (65 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 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT WITH MONONUCLEOSIS SYNDROME, HEPATIC CYTOLYSIS, AND ASTHENIA. THE FOLLOWING DATA WAS PROVIDED (>/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 33.10, REPEAT RESULT WAS 33.04 MIU/ML SAMPLE ID (B)(6) RESULT, ON B)(6) 2025, WAS 33.90 MIU/ML, REPEAT AT BIOMNIS, A DIFFERENT SITE, WAS 34 MIU/ML SAMPLE ID (B)(6) RESULT, ON (B)(6) , WAS 29.17 MIU/ML, REPEAT AT BIOMNIS, DIFFERENT SITE USING THE RADIOIMMUNO ASSAY, WAS <4. IT WAS NOTED THAT THE RESULTS AT BIOMNIS WERE FOR TROUBLESHOOTING PURPOSES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323364 ↗
• MalfunctionNov 5, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG GENERATED FROM AN ARCHITECT I2000SR ANALYZER AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) BHCG RESULT WAS 682.11 IU/L (POSITIVE). THE PATIENT TOOK THE SAME TEST AT ANOTHER LABORATORY, WHICH GENERATED A RESULT OF <1.2 IU/L (NEGATIVE). IT WAS REPORTED THAT THE OTHER LABORATORY USES ABBOTT AS A TESTING PLATFORM. THE ORIGINAL SAMPLE WAS REPEATED AT THE ORIGINAL FACILITY AND GENERATED RESULTS OF <1.2 IU/L & <1.2 IU/L (NEGATIVE). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606410 ↗
• InjuryDec 13, 2023False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON A PATIENT WHO IS BEING TESTED TWO WEEKS AFTER THE IVF PROCEDURE. THE ARCHITECT TOTAL B-HCG RESULT WAS <1.2 MIU/ML (NEGATIVE). THE PATIENT WAS EXPECTED TO HAVE A RESULT OF ABOUT 200 MIU/ML (POSITIVE). THE CUSTOMER STATED THE PATIENT¿S HORMONAL SUPPORT WAS DISCONTINUED. IT WAS NOTED THAT A FROZEN PREGNANCY WAS LATER ESTABLISHED. ADDITIONAL INFORMATION REGARDING THE INCIDENT WAS REQUESTED; HOWEVER, TO DATE, IT HAS NOT BEEN PROVIDED AND/OR RECEIVED. ON 11DEC2023, THE CUSTOMER PROVIDED CLARIFICATION REGARDING THE WORDS ¿FROZEN PREGNANCY¿. THE CUSTOMER STATED IT MEANT AN EARLY UNINTENDED END TO THE PREGNANCY. THE PATIENT¿S SID WAS (B)(6). NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18317922 ↗
• MalfunctionDec 4, 2023False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT OF 4,494 IU/L WAS CONTESTED BY THE PATIENT (ID (B)(6)) WHO HAD RETESTING PERFORMED AT ANOTHER LABORATORY WHERE THE RESULT WAS NEGATIVE. THE CUSTOMER RETESTED THE ARCHIVED PATIENT SAMPLE AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THAT THE PATIENT SAMPLE TESTED PRIOR TO THE SAMPLE IN QUESTION HAD A VERY HIGH B-HCG RESULT OF 75,000 IU/L; THEREFORE, SAMPLE CARRYOVER IS SUSPECTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256861 ↗
• MalfunctionJun 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA ON TWO PATIENTS: PATIENT 1 WAS 29 YEARS OLD. SAMPLE ID: (B)(6). ON 28 APR 2023 B-HCG RESULT WAS NEGATIVE (NO NUMERICAL RESULT PROVIDED). THE PATIENT HAD AN ULTRASOUND THE SAME DAY WHICH CONFIRMED THE PREGNANCY, WHICH WAS REPORTED TO SHOW FETAL LOCATION IN THE UTERINE CAVITY, THE CORRECT OVAL SHAPE, AND MEAN INTERNAL DIAMETER OF THE OVUM WAS 0.9 CM. PATIENT 2 WAS 25 YEARS OLD. SAMPLE ID: (B)(6). ON 29 MAY 2023 RESULT WAS <1.2 MIU/ML. THE SAMPLE WAS REPEATED ON 31 MAY 2023 AND THE RESULT WAS <1.2 MIU/ML. ON 01 JUNE 2023 A NEW SAMPLE WAS OBTAINED (SAMPLE ID (B)(6)), WHICH GENERATED A RESULT OF <1.2 MIU/ML. A RAPID URINE TEST GENERATED A POSITIVE RESULT. IT WAS REPORTED THAT THE SAMPLE WAS RETESTED ON ANOTHER INSTRUMENT IN THE LAB AND GENERATED A RESULT OF <1.2 MIU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183311 ↗
• MalfunctionNov 15, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITEC B-HCG RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR ONE PATIENT. A NEW SAMPLE WAS COLLECTED, AND THE RESULT WAS NEGATIVE. BOTH SAMPLES WERE REPEATED IN DUPLICATE ON ANOTHER ARCHITECT ANALYZER AND GENERATED NEGATIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) INITIAL RESULT = 5051.93 MIU/ML; REPEAT RESULTS ON OTHER ARCHITECT ((B)(4)) = <1.20 MIU/ML AND <1.20 MIU/ML. SID (B)(6) INITIAL RESULT = <1.20 MIU/ML; REPEAT RESULTS ON OTHER ARCHITECT ((B)(4)) = <1.20 MIU/ML AND <1.20 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816367 ↗
• MalfunctionSep 29, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE B-HCG RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER ON AN (B)(6) OLD FEMALE PATIENT WITH ABDOMINAL PAIN. THE INITIAL RESULT = 1770.58 MIU/ML; REPEAT RESULT = <1.20 MIU/ML (CUSTOMER PROVIDED REFERENCE RANGE <5.00 MIU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547018 ↗
• MalfunctionSep 15, 2021False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT A POSITIVE ARCHITECT TOTAL B-HCG RESULT OF 46.71 MIU/ML WAS GENERATED ON (B)(6) 2021 FOR A (B)(6) YEAR OLD FEMALE PATIENT. THE SAME PATIENT TESTED NEGATIVE USING THE ROCHE B-HCG METHOD ON (B)(6) 2021. THE SAMPLE FROM (B)(6) 2021 WAS RETESTED AND THE ARCHITECT TOTAL B-HCG RESULT WAS 17.29 MIU/ML (GRAYZONE). A POSITIVE RESULT WAS GENERATED USING AN ALTERNATE METHOD (COLLOIDAL GOLD METHOD). THE PATIENT'S CLINICAL DIAGNOSIS IS BILATERAL HYDROSALPINX. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474554 ↗
• MalfunctionSep 1, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID 012986677600 INITIAL RESULT, ON 23AUG, WAS 1004.27, REPEATED, UNDER SAMPLE ID 801 ON 25AUG, WAS <1.2 MIU/ML. THE PATIENT WAS REDRAWN ON 25AUG AND THE RESULT WAS <1.2, REPEAT WAS <1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411006 ↗
• MalfunctionAug 13, 2021False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY ELEVATED ARCHITECT B-HCG RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) INITIAL RESULT 1740.75MIU/ML, RETESTED AS SID (B)(6) <1.2 MIU/ML. THE CUSTOMER BELIEVES THE <1.2 MIU/ML RESULT TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319781 ↗
• MalfunctionJul 14, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A PATIENT. ON (B)(6) 2021, SID (B)(6) GENERATED A POSITIVE B-HCG RESULT OF 14921.66 IU/L. THE DOCTOR CONTACTED THE CUSTOMER TO ADVISE THEM THAT THIS PATIENT WAS NOT PREGNANT AND THE POSITIVE B-HCG RESULT DOES NOT CORRELATE WITH THE PATIENTS HISTORY. THE PATIENT ALSO HAD AN ULTRASOUND PERFORMED WHICH CONFIRMS THE PATIENT WAS NOT PREGNANT AT THE TIME THE SAMPLE WAS TESTED. A REPEAT SAMPLE WAS SENT TO ANOTHER PROVIDER AND RUN ON A DIFFERENT PLATFORM WHICH GENERATED A NEGATIVE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170955 ↗
• MalfunctionJul 13, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON 20JUN2021 SID (B)(6) INITIAL =<1.2 MIU/ML (<OR=5.00 MIU/ML=NEGATIVE) /REPEATED=27 MIU/ML AND 29.3 MIU/ML (>OR=25.00 MIU/ML=POSITIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160114 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE):(B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924851 ↗
• MalfunctionFeb 21, 2021False Positive Result; False Positive Result

  THE CUSTOMER GENERATED A (B)(6) ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL RESULT (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356674 ↗
• MalfunctionJan 25, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE = </= 5.00 IU/L = NEGATIVE, >/= 25.00 IU/L = POSITIVE). ON (B)(6) 2021 SID (B)(6) = INITIAL RESULT = 29 IU/L (POSITIVE), REPEAT RESULT = < 1 IU/L (NEGATIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11227376 ↗
• MalfunctionDec 29, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT B-HCG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) = 674.12MIU/ML (>/=25.00MIU/ML = POSITIVE) / RETEST = <1.20MIU/ML (</=5.00MIU/ML = NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11088578 ↗
• MalfunctionDec 28, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL BETA-HCG RESULT FOR A FEMALE PATIENT DIAGNOSED WITH GALACTORRHEA. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 = INITIAL ARCHITECT = 31.5 MIU/ML (>/= 25.00 MIU/ML = POSITIVE); REPEAT = 31 MIU/ML (POSITIVE). ROCHE PLATFORM = NEGATIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11080067 ↗
• MalfunctionDec 18, 2020False Positive Result; False Positive Result

  THE CUSTOMER GENERATED A FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) INITIAL RESULT: 69.43 MIU/ML, RETEST 94.23, 90.7, 83.49, 90.23 AND 90.3 MIU/ML (POSITIVE) RETEST ON ROCHE PLATFORM: 92.9 MIU/ML (POSITIVE). NEW DRAW (SID UNKNOWN), RETEST ON ARCHITECT: <1.2 MIU/ML, RETEST <1.2 MIU/ML AND <1.2 MIU/ML (NEGATIVE). THE PATIENT IS A (B)(6) YEAR OLD FEMALE WITH ABNORMAL UTERINE BLEEDING/SEVERE ANEMIA. THE PATIENT HAD UNDERGONE A BLOOD TRANSFUSION PRIOR TO THE INITIAL BLOOD DRAW. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11041456 ↗
• MalfunctionNov 6, 2020False Positive Result; False Positive Result

  THE CUSTOMER GENERATED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6), INITIAL TEST RESULT: 3444.02 MIU/ML. RETEST RESULT: <1.2 MIU/ML. PATIENT IS FEMALE WITHOUT PREGNANCY REACTIONS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10801712 ↗
• MalfunctionNov 3, 2020False Positive Result; False Positive Result

  THE CUSTOMER GENERATED FALSELY ELEVATED ARCHITECT TOTAL -HCG RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS 36.08 MIU/ML (POSITIVE) AND THE RETEST WAS LESS THAN 1.2 MIU/ML (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10777388 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT (SID 701012087246). THE INITIAL TEST RESULT WAS 3,997.00MIU/ML AND THE RETEST RESULT WAS <1.2MIU/ML. THE FEMALE (B)(6)- YEAR OLD PATIENT REPORTED ABNORMAL UTERINE BLEEDING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10743552 ↗
• MalfunctionOct 5, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020; SID (B)(6) GENERATED INITIAL RESULT OF 262 MIU/ML (POSITIVE) (CUSTOMER REFERENCE RANGE NORMAL <100 MIU/ML); A NEW SAMPLE WAS DRAWN SID (B)(6), AND GENERATED RESULT OF 1.20 MIU/ML (NEGATIVE), REPEATED 1.82 MIU/ML (NEGATIVE). THE PATIENT STATED THAT HER LAST MENSTRUATION WAS ON (B)(6) 2020. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10628988 ↗
• MalfunctionSep 9, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (LESS THAN 5.00 MIU/ML IS NEGATIVE, GREATER THAN EQUAL TO 25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT WAS 269.89 MIU/ML. THE RESULT WAS QUESTIONED BY THE PHYSICIAN, SO THE SAMPLE WAS REPEATED, THE RESULT WAS LESS THAN 1.2 MIU/ML. THE PATIENT WAS REDRAWN, SAMPLE ID (B)(6), AND THE RESULT WAS LESS THAN 1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10512245 ↗
• MalfunctionAug 12, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT. ON (B)(6) 2020 SAMPLE ID (B)(6) GENERATED A POSITIVE RESULT OF 3413.13 IU/L. THE SAMPLE WAS RETESTED ON (B)(6) 2020 AND GENERATED A NEGATIVE RESULT OF <1.2 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10399342 ↗
• MalfunctionJul 20, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT B-HCG RESULT THAT WAS QUESTIONED BY THE DOCTOR WHO STATED THAT THE PATIENT WAS A NON-PREGNANT (B)(6) YEAR-OLD FEMALE. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 = POSITIVE (100.10 MIU/ML) (REFERENCE RANGE >/= TO 25.00 MIU/ML = POSITIVE), REPEATED ON THE SAME SAMPLE ON (B)(6) 2020 = POSITIVE (119.19 MIU/ML). THE CUSTOMER FURTHER RETESTED THE SAMPLE ACROSS THREE ARCHITECT ANALYZERS GENERATING RESULTS RANGING FROM 99.37 TO 122.80 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10298815 ↗