ARCHITECTRecalls & reported problems across all models

We found 23 models of ARCHITECT by Abbott Ireland Diagnostics in the FDA's device registry (GUDID). Together they are named in 174 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2016 and Sep 17, 2026 — classified as 3 injuries, 171 malfunctions.

The most frequently reported specific device problem is “High Test Results” (58 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ARCHITECT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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-1843-2025 · Root cause: Storage · Recall details · FDA record ↗

3. 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-1842-2025 · Root cause: Storage · Recall details · FDA record ↗

4. 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-1841-2025 · Root cause: Storage · Recall details · FDA record ↗

5. Feb 21, 2024Open, Classified

   The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.

   Z-1476-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

6. Mar 8, 2022Open, Classified

   This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

   Z-0891-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported ARCHITECT problems

ARCHITECT models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ARCHITECT 2K43-25

  CALIBRATOR, PRIMARY
  1 recall23 reports
• ARCHITECT 4P53-25

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 recall16 reports
• ARCHITECT 2K43-01

  CALIBRATOR, PRIMARY
  1 recall10 reports
• ARCHITECT 2K43-20

  MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
  1 recall8 reports
• ARCHITECT 1L82-27

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 recall4 reports
• ARCHITECT 1L56-40

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall0 reports
• ARCHITECT 2K47-27

  SYSTEM, TEST, THYROID AUTOANTIBODY
  1 recall0 reports
• ARCHITECT 4P54-25

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  27 reports
• ARCHITECT 3P36-25

  KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
  20 reports
• ARCHITECT 07K68-27

  SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
  13 reports
• ARCHITECT 4P53-35

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  10 reports
• ARCHITECT 3P36-35

  KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
  10 reports
• ARCHITECT 1L77-25

  ENZYME IMMUNOASSAY, TRACROLIMUS
  9 reports
• ARCHITECT 07K68-35

  SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
  8 reports
• ARCHITECT 07K68-32

  SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
  4 reports
• ARCHITECT 1L76-25

  CALIBRATOR, SECONDARY
  2 reports
• ARCHITECT 6C06-27

  PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
  2 reports
• ARCHITECT 1L82-37

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  2 reports
• ARCHITECT 06R8720

  Reagent, coronavirus serological
  2 reports
• ARCHITECT 1L82-25

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 report
• ARCHITECT 1L82-35

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 report
• ARCHITECT 2K42-25

  CALIBRATOR, PRIMARY
  1 report
• ARCHITECT 2K46-20

  SYSTEM, TEST, THYROID AUTOANTIBODY
  1 report

Recent ARCHITECT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Low Test Results

  The customer observed falsely depressed ARCHITECT Myoglobin results for four samples. The following data was provided:Sample 1 initial ARCHITECT Myoglobin result 12 ng/mL, retest 40 ng/mL,Sample 2 initial ARCHITECT Myoglobin result 9.2 ng/mL, retest 31.4 ng/mL,Sample 3 initial ARCHITECT Myoglobin result 91 ng/mL, retest 412.1 ng/mL,Sample 4 initial ARCHITECT Myoglobin result 70 ng/mL, retest 336.6 ng/mL. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803312 ↗
• 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 23945733 ↗
• 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 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULTS FOR ONE PATIENT WHO DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 1.09 - 8.04 NG/ML): (B)(6) 2025 INITIAL ARCHITECT AFP RESULT FOR SID (B)(6) WAS 568.23 NG/ML, REPEATED ON (B)(6) 2025 AND THE RESULT WAS 1.42 NG/ML. THE PATIENT THEN WENT TO ANOTHER LABORATORY WHERE THE RESULT WAS REPORTED AS WITHIN NORMAL LIMITS (VALUE UNAVAILABLE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878994 ↗
• MalfunctionAug 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY. 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 20055844 ↗
• MalfunctionAug 23, 2024False Positive Result; High Test Results; False Positive Result; High Test Results

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048316 ↗
• 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 ↗
• MalfunctionAug 6, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING FOR A PATIENT. THE SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER DOES NOT HAVE ANY INFORMATION REGARDING THE PATIENT¿S DIAGNOSIS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT = 294.14 NG/ML. (B)(6) 2024 SID (B)(6) RERUN RESULT = 5.93 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920734 ↗
• MalfunctionJul 22, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED PERFORMANCE ISSUES DURING PREVIOUS PROFICIENCY SURVEYS AND QUALITY CONTROL ISSUE WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23 ON THE ARCHITECT I1000 PROCESSING MODULE, SN (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798446 ↗
• MalfunctionJun 21, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER OBSERVED THAT QUALITY CONTROL WERE OUT OF RANGE HIGH FOR ALL THREE LEVELS WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I1000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579989 ↗
• MalfunctionJun 20, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER OBSERVED THAT QUALITY CONTROL WERE OUT OF RANGE HIGH FOR ALL THREE LEVELS WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I1000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579218 ↗
• MalfunctionJun 4, 2024Product Quality Problem; Failure to Calibrate; Product Quality Problem; Failure to Calibrate

  THE CUSTOMER OBSERVED THAT MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I2000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461962 ↗
• MalfunctionMay 17, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED THAT MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED TO BE DIFFERENT THAN EXPECTED AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST (B)(4), LOT 50808UN23 ON THE ARCHITECT I2000 PROCESSING MODULE, SN (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342704 ↗
• MalfunctionMay 14, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT AUSAB RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL AUSAB RESULT = 19.64 MIU/ML, REPEAT RESULT = 0.48 MIU/ML, REPEAT RESULT ON ((B)(6)) 0.12 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309515 ↗

Other Abbott Ireland Diagnostics products

• Alinity15 models · 155 reports · 2 recalls