ARCHITECT 4P53-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380740007782), received between Aug 22, 2016 and Aug 23, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6), INITIAL HBSAG= REACTIVE; REPEATED IN DUPLICATE= REACTIVE; NEUTRALIZING CONFIRMATORY TESTING= REACTIVE. THE PATIENT SAMPLE WAS SENT OUT TO A REFERENCE LAB ON (B)(6) 2024, HBSAG CAME BACK NON-REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048264 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSELY REACTIVE ARCHITECT HBSAG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. ADDITIONALLY, THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATES FROM (B)(4) FOR (B)(6)2023. (B)(6) 2023 INITIAL REACTIVE SAMPLES WERE RECENTRIFUGED AND REPEAT REACTIVE IN DUPLICATE WITH CONFIRMED POSITIVE RESULTS THAT HAD SIMILAR S/CO VALUES AND % NEUTRALIZATION (NO SPECIFIC DATA WAS PROVIDED). (B)(6) 2023 AN OBSTETRIC GYNECOLOGY (OBGYN) PHYSICIAN QUESTIONED A CONFIRMED POSITIVE RESULT FOR A MOTHER OF A NEWBORN. THE PATIENTS THAT WERE REDRAWN WERE NEGATIVE FOR HBSAG AND THE VIRAL LOAD TESTING WAS PERFORMED ON 2 OF THE PATIENTS (ON THE REDRAWN SAMPLE) WERE NEGATIVE. THE SAMPLES THAT WERE REPEAT REACTIVE AND CONFIRMED REACTIVE WERE FROM OUTPATIENT LABORATORY SITES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953111 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSELY REACTIVE ARCHITECT HBSAG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. ADDITIONALLY, THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATES FROM 2% TO 19% FOR (B)(6) 2023. (B)(6) 2023 INITIAL REACTIVE SAMPLES WERE RECENTRIFUGED AND REPEAT REACTIVE IN DUPLICATE WITH CONFIRMED POSITIVE RESULTS THAT HAD SIMILAR S/CO VALUES AND % NEUTRALIZATION (NO SPECIFIC DATA WAS PROVIDED). (B)(6) 2023 AN OBSTETRIC GYNECOLOGY (OBGYN) PHYSICIAN QUESTIONED A CONFIRMED POSITIVE RESULT FOR A MOTHER OF A NEWBORN. THE PATIENTS THAT WERE REDRAWN WERE NEGATIVE FOR HBSAG AND THE VIRAL LOAD TESTING WAS PERFORMED ON 2 OF THE PATIENTS (ON THE REDRAWN SAMPLE) WERE NEGATIVE. THE SAMPLES THAT WERE REPEAT REACTIVE AND CONFIRMED REACTIVE WERE FROM OUTPATIENT LABORATORY SITES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950469 ↗
• MalfunctionJul 17, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ARCHITECT (B)(6) RESULTS ON TWO PATIENTS: RESULTS PROVIDED: ON (B)(6) 2020 SID (B)(6) = 2.09 / 3.55 / 1.89 S/CO, CONFIRMED POSITIVE BY (B)(6) NEUTRALIZATION CONFIRMATORY; REPEATED ON (B)(6) 2020 = 0.12 S/CO, CONFIRMATION = NEGATIVE. ON (B)(6) 2020 SID (B)(6) = 1.19 / 1.32 / 1.6 S/CO, CONFIRMED POSITIVE BY (B)(6) NEUTRALIZATION CONFIRMATORY; REPEATED ON (B)(6) 2020 = 0.52 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10288797 ↗
• MalfunctionMay 1, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) QUALITATIVE RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. ADDITIONAL RNA/DNA TESTING WAS (B)(6). THE INITIAL RESULT WAS (B)(6) AND RETEST RESULTS WERE (B)(6). A NEW SAMPLE WAS DRAWN AND YIELDED RESULTS OF (B)(6). ANOTHER RETEST OF THE ORIGINAL SAMPLE GENERATED RESULTS OF (B)(6). CONFIRMATORY AND NEUTRALIZATION TESTING YIELDED RESULTS OF (B)(6), RESPECTIVELY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8568733 ↗
• MalfunctionMar 2, 2019False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSELY REACTIVE RESULTS WHILE USING ARCHITECT HBSAG REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL (B)(6), REPEAT (B)(6). MULTIPLE HBSAG QUALITATIVE RESULTS WERE (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384797 ↗
• MalfunctionFeb 13, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT HBSAG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) = (B)(6); CONFIRMATORY TESTING (B)(6). THE CUSTOMER QUESTIONED THE RESULTS BECAUSE THE AUSAB RESULT = (B)(6), SO THEY RETESTED THE SAMPLE = (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336403 ↗
• MalfunctionMar 8, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) RESULTS, WHILE USING THE ARCHITECT (B)(6) QUALITATIVE AND ARCHITECT (B)(6) QUALITATIVE CONFIRMATORY ASSAYS. SAMPLE ID (B)(6) GENERATED A REPEAT REACTIVE (B)(6) RESULT OF 1.61, 13.08 AND 5.04 S/CO) AND CONFIRMATORY TESTING CONFIRMED AT 93%. THE ORIGINAL AND A SECOND SAMPLE FROM THE PATIENT WERE RETESTED IN DUPLICATE GENERATING NEGATIVE RESULTS RANGING FROM 0.16 TO 0.33 S/CO. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7325338 ↗
• MalfunctionDec 27, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT (B)(6) RESULT FROM A FEMALE DIALYSIS PATIENT. SAMPLE ID (B)(6) GENERATED A (B)(6) RESULT OF (B)(6). A NEW SAMPLE (SID (B)(6) ) COLLECTED TWO DAYS LATER GENERATED REPEAT (B)(6) RESULTS ((B)(6)) AND CONFIRMED (B)(6) (93% NEUTRALIZATION). BOTH SAMPLES WERE RETESTED SID (B)(6) GENERATED A (B)(6) ) RESULT AND SID (B)(6) GENERATED (B)(6). NO FURTHER INFORMATION WAS PROVIDED AND NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7148684 ↗
• MalfunctionAug 22, 2016False Positive Result; False Positive Result

  THE ACCOUNT GENERATED A REACTIVE, CONFIRMED POSITIVE ARCHITECT HBSAG QUALITATIVE RESULT ON A CHILD. THE ACCOUNT QUESTIONED THE CONFIRMED POSITIVE HBSAG RESULTS AS ALL OTHER HEPATITIS MARKERS WERE NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5895276 ↗