ARCHITECT 4P53-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380740007775), received between Feb 6, 2017 and Jan 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1847-2025 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ARCHITECT HBSAG QUALITATIVE RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: INITIAL=1.23 S/CO (> OR =1.00 S/CO=REACTIVE) /REPEATED AFTER REDRAWN MULTIPLE TIMES SAME PATIENT=1.6, 1.7 AND 1.33 S/CO. HBSAG QUAL CONFIRMATORY C2=1.55 S/CO; % NEUTRALIZATION=99% (C2=> OR =0.70 S/CO AND % NEUTRALIZATION=> OR =50%=CONFIRMED POSITIVE). ADDITIONAL INFORMATION PROVIDED: ALL OTHER HEPATITIS B MARKERS ARE NEGATIVE (NO ACTUAL RESULTS PROVIDED). ADDITIONAL INFORMATION PROVIDED ON 05JAN2026: SID: (B)(6): 49YRS OLD MALE: INITIAL=1.44 S/CO /REPEATED=1.50 AND 1.49 S/CO /REPEATED WITH LOT NUMBER: 81084FZ00=1.75, 1.43 AND 1.38 S/CO; NEUTRALIZATION TEST: C2=1.39 S/CO AND % NEUTRALIZATION=101.7% THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059731 ↗
• MalfunctionJan 2, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ARCHITECT HBSAG QUALITATIVE RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: INITIAL=1.23 S/CO (> OR =1.00 S/CO=REACTIVE) /REPEATED AFTER REDRAWN MULTIPLE TIMES SAME PATIENT=1.6, 1.7 AND 1.33 S/CO HBSAG QUAL CONFIRMATORY C2=1.55 S/CO; % NEUTRALIZATION=99% (C2=> OR =0.70 S/CO AND % NEUTRALIZATION=> OR =50%=CONFIRMED POSITIVE) ADDITIONAL INFORMATION PROVIDED: ALL OTHER HEPATITIS B MARKERS ARE NEGATIVE (NO ACTUAL RESULTS PROVIDED) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945555 ↗
• MalfunctionMar 22, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE (B)(6) ARCHITECT HBSAG CONFIRMATORY RESULTS ON ONE DIALYSIS PATIENT. THE RESULTS PROVIDED WERE: IN (B)(6) 2020 THE PATIENT WAS INITIAL (B)(6) QUALITATIVE (B)(6) THAT CONFIRMED (B)(6) / SID (B)(6) (B)(6) 2021 INITIAL = (B)(6), NO RETESTING PERFORMED / REDRAW (B)(6) 2021 INITIAL = (B)(6) / RE-SPUN AND RETESTED IN DUPLICATE = (B)(6) / ON (B)(6) 2021 REDRAWN QUALITATIVE = (B)(6), CONFIRMED (B)(6) = CONFIRMED (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542236 ↗
• MalfunctionSep 23, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE RESULTS ON TWO PATIENTS. THE CUSTOMER WAS INITIALLY QUESTIONING THE BIG DIFFERENCE BETWEEN THE ORIGINAL REACTIVE RESULTS (5.37 S/CO) VS THE REPEATS (41.55 / 37.80 S/CO). THIS LEAD THE CUSTOMER INTO REPEATING THE TEST THE FOLLOWING DAY WHICH GENERATED NONREACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2020, SID: (B)(6), GENERATED INITIAL RESULT = 5.37 S/CO (REACTIVE), REPEATED 41.55 S/CO (REACTIVE), 37.80 S/CO (REACTIVE), 0.18 S/CO (NONREACTIVE), 0.17 S/CO (NONREACTIVE), CONFIRMATORY RESULT = 0.74 S/CO % NEUTRALIZATION = 106% (CONFIRMED REACTIVE). SID: (B)(6), GENERATED INITIAL RESULT = 2.90 S/CO (REACTIVE), REPEATED 1.71 S/CO (REACTIVE), 0.79 S/CO (NONREACTIVE), 31.75 S/CO (REACTIVE), 30.26 S/CO (REACTIVE), 10.41 S/CO (REACTIVE), 10.35 S/CO (REACTIVE); (REFERENCE RANGE <1.00 = NONREACTIVE, >/= TO 1.00 = REACTIVE). SID: (B)(6) AND SID: (B)(6) GENERATED NONREACTIVE RESULTS AT A REFERENCE LAB. THE CUSTOMER DID NOT PERFORM CONFIRMATORY TESTING FOR THE SID (B)(6). NO RESULT WAS RELEASED TO THE PROVIDER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10576757 ↗
• MalfunctionNov 22, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT HBSAG RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = (B)(6), CONFIRMED (B)(6) BY HBSAG NEUTRALIZING CONFIRMATORY ASSAY (B)(6). THE PHYSICIAN QUESTIONED THE RESULT, SAMPLE WAS SENT OUT FOR ADDITIONAL TESTING THAT PRODUCED A (B)(6) RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9361562 ↗
• MalfunctionOct 28, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ARCHITECT (B)(6) RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) = 1.38 / 1.29 / 1.43 S/CO. ARCHITECT (B)(6) QUALITATIVE CONFIRMATORY TESTING = 102.364 (CONFIRMED REACTIVE). PATIENT WAS NONREACTIVE ON (B)(6) 2019 AND (B)(6) 2019 (NO DATA PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244819 ↗
• MalfunctionSep 2, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT HBSAG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2019 INITIAL = (B)(6) / ON (B)(6) 2019 REPEATED = (B)(6). THE SAMPLE WAS SENT TO LABCORP WHERE THEY GENERATED (B)(6) RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953827 ↗
• MalfunctionJun 17, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED (B)(6) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) ON (B)(6) 2019 REPEAT (B)(6) TESTING = CONFIRMED / ON (B)(6) 2019 SAME PATIENT NEW SAMPLE SID (B)(6) / SAME PATIENT NEW SAMPLE ON (B)(6) 2019 (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704798 ↗
• MalfunctionMar 11, 2019False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A (B)(6) HBSAG RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6). CONFIRMED (B)(6). THE SAMPLE WAS CONFIRMED (B)(6) AT ANOTHER LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409130 ↗
• MalfunctionFeb 7, 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 8315587 ↗
• MalfunctionNov 19, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING ARCHITECT HBSAG QUALITATIVE REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) TESTED (B)(6) 2018 INITIAL (B)(6), REPEAT IN DUPLICATE WAS (B)(6) HOWEVER ONLY ONE (B)(6) REPEAT RESULT WAS PROVIDED ((B)(6)) AND WAS FLAGGED AS EXP. RETESTING AFTER RECENTRIFUGING THE SPECIMEN WAS (B)(6), THE CUSTOMER DID NOT PROVIDE THE VALUE. A PREVIOUS SPECIMEN TESTED (B)(6) 2018 WAS (B)(6). A SUBSEQUENT SPECIMEN TESTED (B)(6) 2018 WAS ALSO (B)(6). CONFIRMATORY TEST WAS (B)(6) HOWEVER NO SPECIFIC VALUE WAS PROVIDED. THE CUSTOMER STATED THE PATIENT WAS (B)(6) THREE MONTHS BEFORE THE CURRENT TEST AND WAS (B)(6), HOWEVER NO SPECIFIC VALUE OR METHOD WAS PROVIDED. THE PATIENT WAS PREGNANT AND WAS ABOUT TO GIVE BIRTH WHEN THE INITIAL SPECIMEN WAS DRAWN. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086355 ↗
• MalfunctionAug 16, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY REACTIVE RESULTS WHILE USING ARCHITECT HBSAG QUALITATIVE REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (TESTED (B)(6) 2018) INITIAL (B)(6), REPEAT (B)(6). CONFIRMATORY TESTING WAS (B)(6) . PCR METHOD WAS (B)(6). SID (B)(6) (TESTED (B)(6) 2028) INITIAL (B)(6), REPEAT (B)(6). CONFIRMATORY TESTING WAS (B)(6). THE CUSTOMER STATED THE SAME SPECIMEN WAS REPEATED AN HOUR AND A HALF LATER AND (B)(6) RESULTS WERE OBSERVED FOR BOTH METHODS, HOWEVER THE SPECIFIC VALUES WERE NOT PROVIDED. PCR METHOD WAS (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7791588 ↗
• MalfunctionSep 28, 2017False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE (2.61, 2.60, 2.60 S/CO) ARCHITECT HBSAG RESULT FOR A (B)(6) MALE DIALYSIS PATIENT. THE CUSTOMER FURTHER INDICATED THE ARCHITECT HBSAG CONFIRMATORY RESULT WAS 98%. THE CUSTOMER FURTHER INDICATED A MONTH LATER THE PATIENT GENERATED NON REACTIVE RESULTS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901145 ↗
• MalfunctionJul 12, 2017False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE CONFIRMED POSITIVE (B)(6) QUALITATIVE ON A PATIENT WHO REPEATED (B)(6) NEGATIVE WITH A NEW SAMPLE AND VIRAL LOAD NEGATIVE. DATA PROVIDED WAS (B)(6) QUALITATIVE REACTIVE (2.46, 1.20, 1.20 S/CO) AND (B)(6) QUALITATIVE CONFIRMATORY POSITIVE (1.18 S/CO, 95% NEURALIZATION). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6706807 ↗
• MalfunctionApr 11, 2017False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT A WEAK REACTIVE ARCHITECT HBSAG RESULT WAS GENERATED FOR A PATIENT ON (B)(6) 2017. THE SAMPLE RETESTED REACTIVE AND CONFIRMED POSITIVE. THE SAME PATIENT WAS REDRAWN THE FOLLOWING DAY AND THE RESULT WAS NONREACTIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS NONREACTIVE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6483162 ↗
• MalfunctionFeb 6, 2017High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED A (B)(66) RESULT ON A LABOR AND DELIVERY PATIENT. THE RESULTS FROM (B)(6) 2017 =1.43S/CO / SAMPLE REPEATED = 1.36S/CO (>/=1.00S/CO = (B)(6)) / CONFIRMATORY TESTING PERFORMED = C2 1.30 / NEUTRALIZATION = 102.94% (C2 >/=0.70 AND % NEUT >/=50% = CONFIRMED (B)(6)). PHYSICIAN QUESTIONED THE RESULTS AND REQUESTED A NEW SAMPLE, DRAWN (B)(6) 2017 = 0.75S/CO (<1.00S/CO = (B)(6)). THE CUSTOMER RETESTED THE (B)(6) 2017 SAMPLE AFTER RE-CENTRIFUGING AND GENERATED 1.36 / 1.41 / REPEATED CONFIRMATORY = C2 1.30 / 100.619% NEUT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304385 ↗