ARCHITECT 7K78-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00380740014964), received between Nov 7, 2016 and Feb 5, 2026 — classified as 2 injuries, 174 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (119 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL BHCG RESULTS. ON (B)(6) 2026 SID (B)(6) (30 YEAR OLD FEMALE) POSITIVE (80 MIU/ML) REDRAW IN A DIFFERENT LAB WAS NEGATIVE. ON (B)(6) 2026 SID (B)(6) (23 YEAR OLD FEMALE) POSITIVE (209 MIU/ML) REDRAW IN A DIFFERENT LAB WAS NEGATIVE. ON (B)(6) 2026 SID (B)(6) (34 YEAR OLD FEMALE) POSITIVE, REDRAW IN A DIFFERENT LAB WAS NEGATIVE. THE PATIENTS ARE ON IUD/BIRTH CONTROL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270161 ↗
• MalfunctionJan 13, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR A 30-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) ((B)(6) 2025) 128.58 MIU/ML, REPEATED ((B)(6) 2025) <1.20 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056768 ↗
• MalfunctionDec 9, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT B-HCG GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR A FEMALE PATIENT. SID (B)(6). INITIAL RESULT = 104 IU/ML, REPEAT RESULT = 1.2 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757313 ↗
• MalfunctionNov 13, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE ARCHITECT B-HCG ASSAY FOR A 32YRS OLD FEMALE PATIENT UNDERGOING IVF TREATMENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=< 1.20 MIU/ML (NEGATIVE=< OR=5.00 MIU/ML) /RAPID PREGNANCY TEST=POSITIVE. REDRAWN AND REPEATED ON (B)(6) 2025 SID (B)(6)= >15000 MIU/ML (POSITIVE= > OR =25.00 MIU/ML) /REPEATED= >15000 MIU/ML. ON (B)(6) 2025 AUTO DILUTION 1:15 FROM (B)(6) 2025 SPECIMEN SID (B)(6) =20525.96 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542601 ↗
• InjuryNov 5, 2025False Positive Result; False Positive Result

  AN ARTICLE BY JAROSLAV RACEK, IVANA POTOCOVÁ, DANIEL RAJDL, LADISLAV TREFIL, MARIE ¿OLCOVÁ. ¿FALSE POSITIVE RESULT OF HUMAN CHORIONIC GONADOTROPIN CAUSED BY HUMAN ANTI-MOUSE ANTIBODIES¿, BIOCHEM MED (ZAGREB) 2023;33(1):010802. THE STUDY NOTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS (1450 U/L) ON A 45-YEAR-OLD WOMAN THE PATIENT WAS SENT TO A REGIONAL HOSPITAL WITH THE DIAGNOSIS OF PREGNANCY OF UNKNOWN LOCALIZATION, TO EXCLUDE ECTOPIC PREGNANCY. HERE, DUE TO A SLIGHT DECREASE IN HCG CONCENTRATION, SHE UNDERWENT A REVISION OF HER UTERINE CAVITY WITH A NEGATIVE FINDING. AS THERE WAS ANOTHER SLIGHT DECREASE IN THE HCG CONCENTRATION THE NEXT DAY, THE UTERINE CAVITY REVISION WAS REPEATED AND SUPPLEMENTED WITH A LAPAROSCOPIC EXAMINATION WHERE THE GESTATIONAL SAC COULD NOT BE FOUND. THE PATIENT WAS THEN TRANSFERRED TO A UNIVERSITY HOSPITAL WHERE METHOTREXATE ADMINISTRATION WAS CONSIDERED. HOWEVER, BLOOD WAS FIRST DRAWN FOR HCG DETERMINATION: < 1 U/L (REAGENT KIT ELECSYS HCG+¿B, BASED ON ELECTROCHEMILUMINESCENCE (ECLIA), COBAS E602 ANALYZER (ROCHE DIAGNOSTICS) IN TWO DIFFERENT SAMPLES. ONE OF THE ABOVE-MENTIONED SAMPLES WAS THEN SENT TO TWO OTHER LABORATORIES TO OBTAIN RESULTS USING KIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474580 ↗
• MalfunctionAug 12, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT ON A FEMALE PATIENT. RESULTS WERE REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED: (= 5.00 MIU/ML IS NEGATIVE, >5.00 TO <25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): (B)(6) 2025; SID (B)(6), INITIAL RESULT = 730.1 MIU/ML(POSITIVE), REPEAT RESULT = < 1.2 MIU/ML. (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790776 ↗
• MalfunctionJul 16, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE PATIENT WAS POSITIVE BY ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: ARCHITECT INITIAL RESULT = <1.20 MIU/ML RETESTED WITH ANOTHER REAGENT SAME LOT = <1.20 MIU/ML IMMUNOCHROMATOGRAPHY METHOD WAS POSITIVE WITH A URINE SAMPLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520859 ↗
• MalfunctionJun 6, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT B-HCG RESULTS ON A PREGNANT PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=1.32 MIU/ML (NEGATIVE, OR= 5.00 MIU/ML) /REPEATED ON (B)(6) 2025=2801.71 MIU/ML (POSITIVE OR =25.00 MIU/ML) /REPEATED ON CARD TEST=POSITIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158959 ↗
• MalfunctionMay 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6) = 329.72 / REPEAT WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104635 ↗
• MalfunctionMay 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TOTAL HCG RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6), SID (B)(6) INITIAL RESULT = 600.37 IU/L, NEW SAMPLE RESULT = <1.2 IU/L (B)(6) 2025 REPEAT RESULT FROM PREVIOUS SAMPLE = >1.2 IU/L THE FOLLOWING RESULTS WERE PROVIDED AND THE FOUR SIDS ARE FOR THE SAME PATIENT: (B)(6) 2025 SID (B)(6) INITIAL RESULT 31.28 IU/L, REPEAT RESULTS WITH (B)(6) = <1.20 IU/L, SID KERR967RPT = <1.20 IU/L, SID KERR1108RPT = <1.20 IU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970333 ↗
• MalfunctionMar 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR A 33-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT 1316.87 MIU/ML, REPEATED < 1.2 MIU/ML. NEW COLLECTION PERFORMED (B)(6) 2025 SID (B)(6) RESULT < 1.2 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620905 ↗
• MalfunctionJan 23, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA FOR 1 SAMPLE: ON (B)(6) 2025, SAMPLE ID (B)(6) INITIAL RESULT WAS 468.37 MIU/ML (POSITIVE) AND REPEAT RESULTS WERE < 1.20 MIU/ML (NEGATIVE) & < 1.20 MIU/ML (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21226470 ↗
• MalfunctionDec 27, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6) = 2.02 / 99.34 / 179.96 / 191.26 MIU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026714 ↗
• MalfunctionDec 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 42.06 IU/L REPEAT RESULT = <1.20 IU/L REPEATED AFTER SERVICE VISIT = <1.20 IU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881714 ↗
• MalfunctionNov 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6). INITIAL = 136.56 MIU/ML, REPEAT = <1.20 MIU/ML, REPEAT ON ANOTHER ARCHITECT = < 1.20 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745235 ↗
• MalfunctionAug 4, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) INITIAL BHCG RESULT WAS 361.08 MIU/ML (POSITIVE). THE CLINICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF < 1.2 MIU/ML (NEGATIVE). REFERENCE: ARCHITECT TOTAL B-HCG PACKAGE INSERT REFERENCE RANGE: = 5.00 MIU/ML IS NEGATIVE, = 25.00 MIU/ML IS POSITIVE, GREATER THAN 5.00 MIU/ML AND LESS THAN 25.00 MIU/ML WILL BE REPORTED WITH CONCENTRATIONS ONLY (GRAYZONE), WHICH NO INTERPRETATION WILL BE REPORTED FOR THESE GRAYZONE RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903484 ↗
• MalfunctionJul 22, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >15000 MIU/ML, REPEAT RESULT WAS AROUND 53000 MIU/ML THE RESULTS GENERATED DID NOT MATCH CLINICAL PRESENTATION AND A NEW SAMPLE WAS COLLECTED (SID (B)(6)) WHICH GENERATED A NEGATIVE RESULT. THE ORIGINAL SAMPLE WAS REPEATED WHICH ALSO GENERATED A NEGATIVE RESULT. BOTH SAMPLES WERE REPEATED ON ANOTHER ARCHITECT AND GENERATED NEGATIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793275 ↗
• MalfunctionJul 8, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LAB. THE FOLLOWING RESULTS WERE PROVIDED (NORMAL RANGE: <5 MIU/ML NONPREGNANT; 5 TO 25 MIU/ML CLINICAL CONSIDER; >25 MIU/ML: PREGNANCY): SID (B)(6) , SERUM TUBE: INITIAL RESULT= 2070.92 IU/L (POSITIVE); REPEAT WITH 1:15 DILUTION < 7000.00 MIU/L (POSITIVE); REPEAT RESULT= 1855.71 IU/L (POSITIVE); EDTA TUBE: INITIAL RESULT < 1.20 IU/L (NEGATIVE); REPEAT RESULTS < 1.20 IU/L (NEGATIVE) AND < 1.20 IU/L (NEGATIVE) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692542 ↗
• MalfunctionJun 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1, SID (B)(6): (B)(6) 2024 = 528.32 MIU/ML (B)(6) 2024 = < 1.20 MIU/ML (B)(6) 2024 = < 1.20 MIU/ML (B)(6) 2024 = < 1.20 MIU/ML THESE ARE SAMPLES FROM DIFFERENT COLLECTIONS. PATIENT 2, SID (B)(6): (B)(6) 2024 = 277.92 MIU/ML (B)(6) 2024 = < 1.20 MIU/ML THE RESULTS ABOVE ARE FROM THE SAME SAMPLE. THE REFERENCE RANGE FOR B-HCG IS </= 5.00 MIU/ML IS NEGATIVE, > /= 25.00 MIU/ML IS POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541226 ↗
• MalfunctionMay 8, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT B-HCG RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR ONE PATIENT. SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) 2024 = 308.19 MIU/ML. FRESH SAMPLE ID (B)(6) RESULT ON (B)(6) 2024 = <1.20 MIU/ML. REPEAT OF BOTH SAMPLES ON (B)(6) 2024 GENERATED RESULTS = <1.20 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269512 ↗
• MalfunctionMay 1, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULTS THAT WERE INCONSISTENT WITH CLINICAL PICTURE ON (B)(6) 2024. THE CUSTOMER RETESTED ON (B)(6) 2024 AND THE RESULTS WERE POSITIVE, WHICH WAS ALIGNED WITH THE PATIENT¿S CLINICAL OBSERVATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221758 ↗
• MalfunctionApr 29, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (</=5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2024, WAS 56.53 IU/ML, WHICH WAS RELEASED FROM THE LABORATORY. THE RESULT WAS QUESTIONED, SO THE SAMPLE WAS REPEATED ON (B)(6) 2024, AND THE RESULT WAS 60.13 IU/ML. THE PATIENT WAS RECOLLECTED, UNDER SAMPLE ID (B)(6) AND THE RESULT WAS 61.36 IU/ML. THE SAMPLES WERE THEN SENT TO A REFERENCE LABORATORY WHERE SAMPLE ID (B)(6) RESULT WAS <0.60 IU/ML, WHICH IS NEGATIVE AND SAMPLE ID (B)(6) RESULT WAS <0.60 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203815 ↗
• MalfunctionMar 19, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR ONE PATIENT. THE INITIAL RESULT FOR SID: (B)(6) WAS 306.05 MIU/ML, RE-TEST <1.2 MIU/ML (REFERENCE RANGE <5 UNIT: MIU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934904 ↗
• MalfunctionFeb 27, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULTS FOR A 34-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2024, WAS 3.39, REPEAT RESULTS WERE 399.01 AND 4.38 MIU/ML. THE SAMPLE WAS ALSO TESTED FOR TROUBLESHOOTING WITH AN ALINITY ASSAY, AND THE RESULT WAS 154.01, REPEAT RESULTS WERE 424.30 AND 410.45 MIU/ML. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE RESULT WAS 3.75 MIU/ML. THE PATIENT¿S PREVIOUS RESULT ON (B)(6) 2024 WAS 187.0, ON (B)(6) 2024 WAS 29.0, AND ON (B)(6) 2024 WAS <1.20 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790623 ↗
• MalfunctionFeb 5, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT B-HCG RESULTS ON ONE FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 ,SID (B)(6), INITIAL=2094.07 MIU/ML (> OR =25.00 MIU/ML=POSITIVE) /REPEATED=< 1.2 MIU/ML (< OR =5.00 MIU/ML=NEGATIVE) /REPEATED ON (B)(6) 2024=< 1.2 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645767 ↗