ARCHITECTRecalls & reported problems across all models

We found 48 models of ARCHITECT by Abbott GmbH in the FDA's device registry (GUDID). Together they are named in 526 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2016 and Mar 19, 2026 — classified as 6 injuries, 520 malfunctions.

The most frequently reported specific device problem is “High Test Results” (385 reports).

8 FDA recall records name at least one of these models by its device identifier, 4 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-1845-2025 · 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-1840-2025 · Root cause: Storage · Recall details · FDA record ↗

3. Mar 4, 2024Open, Classified

   Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

   Z-1479-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

4. Jun 9, 2022Open, Classified

   There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

   Z-1454-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Mar 9, 2020Terminated

   An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

   Z-1728-2020 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

6. May 24, 2019Terminated

   Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

   Z-2079-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 24, 2019Terminated

   Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

   Z-2078-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Dec 14, 2017Terminated

   Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.

   Z-1629-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported ARCHITECT problems

ARCHITECT models

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

• ARCHITECT 6L27-25

  KIT, SEROLOGICAL, NEGATIVE CONTROL
  1 recall111 reports
• ARCHITECT 08K2803

  Calibrator, secondary
  1 recall93 reports
• ARCHITECT 08K2812

  Single (specified) analyte controls (assayed and unassayed)
  1 recall12 reports
• ARCHITECT 1L79-25

  ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
  1 recall7 reports
• ARCHITECT 1L79-35

  ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
  1 recall3 reports
• ARCHITECT 4P52-20

  Hemoglobin A1c test system
  1 recall2 reports
• ARCHITECT 2P36-01

  Test, hiv detection
  1 recall0 reports
• ARCHITECT 8K27-25

  RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)
  1 recall0 reports
• ARCHITECT 1E64-03

  Calibrator, multi-analyte mixture
  1 recall0 reports
• ARCHITECT 03P6822

  PHOTOMETRIC METHOD, MAGNESIUM
  43 reports
• ARCHITECT 3L80-22

  ENZYMATIC, CARBON-DIOXIDE
  31 reports
• ARCHITECT 6L45-22

  DIAZO COLORIMETRY, BILIRUBIN
  30 reports
• ARCHITECT 03P6832

  PHOTOMETRIC METHOD, MAGNESIUM
  22 reports
• ARCHITECT 3L79-22

  AZO DYE, CALCIUM
  17 reports
• ARCHITECT 3L79-32

  AZO DYE, CALCIUM
  15 reports
• ARCHITECT 6L45-42

  DIAZO COLORIMETRY, BILIRUBIN
  15 reports
• ARCHITECT 2P56-22

  NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
  13 reports
• ARCHITECT 8K25-27

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  12 reports
• ARCHITECT 3L81-33

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  9 reports
• ARCHITECT 02K4529

  TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
  8 reports
• ARCHITECT 3L81-23

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  8 reports
• ARCHITECT 3L82-22

  HEXOKINASE, GLUCOSE
  8 reports
• ARCHITECT 08K4128

  RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
  8 reports
• ARCHITECT 2P36-25

  Test, hiv detection
  7 reports
• ARCHITECT 4P52-01

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  4 reports
• ARCHITECT 2K91-33

  Single (specified) analyte controls (assayed and unassayed)
  4 reports
• ARCHITECT 3L80-32

  ENZYMATIC, CARBON-DIOXIDE
  4 reports
• ARCHITECT 3L82-42

  HEXOKINASE, GLUCOSE
  4 reports
• ARCHITECT 6L21-25

  Hepatitis a test (antibody and igm antibody)
  3 reports
• ARCHITECT 6L22-25

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  3 reports
• ARCHITECT 8D06-31

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  3 reports
• ARCHITECT 7P32-21

  BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
  3 reports
• ARCHITECT 02K4539

  TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
  3 reports
• ARCHITECT 2P56-42

  NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
  3 reports
• ARCHITECT 1P31-25

  ENZYME IMMUNOASSAY, GENTAMICIN
  2 reports
• ARCHITECT 8D06-41

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  2 reports
• ARCHITECT 08K2529

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  2 reports
• ARCHITECT 7D71-23

  Phosphomolybdate (colorimetric), inorganic phosphorus
  2 reports
• ARCHITECT 2P36-35

  Test, hiv detection
  1 report
• ARCHITECT 6L27-01

  CALIBRATOR, PRIMARY
  1 report
• ARCHITECT 1P36-27

  ENZYME IMMUNOASSAY, CARBAMAZEPINE
  1 report
• ARCHITECT 8D06-13

  ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  1 report
• ARCHITECT 1P30-28

  RADIOIMMUNOASSAY, VANCOMYCIN
  1 report
• ARCHITECT 01P3227

  ENZYME IMMUNOASSAY, DIGOXIN
  1 report
• ARCHITECT 7D56-22

  NADH OXIDATION/NAD REDUCTION, ALT/SGPT
  1 report
• ARCHITECT 7D58-22

  CATALYTIC METHODS, AMYLASE
  1 report
• ARCHITECT 7D63-22

  NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
  1 report
• ARCHITECT 7D81-22

  Nadh oxidation/nad reduction, ast/sgot
  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.

• MalfunctionMar 19, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT INSULIN RESULT FOR A 35 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT WAS >300 UU/ML, REPEAT WITH 1:2 AUTOMATIC DILUTION WAS >600 UU/ML THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHICH GENERATED A RESULT OF 13.20 UU/ML WITH ROCHE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638965 ↗
• MalfunctionMar 5, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE 3 DAY OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL TEST 2.60 MMOL/L, RETEST 0.98 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519781 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: SID (B)(6) = 689 / 62.3 UMOL/L (REFERENCE RANGE: 57-111 UMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879374 ↗
• MalfunctionDec 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED BILIRUBIN GENERATED FROM ARCHITECT ANALYZER. AFTER RECALIBRATION, RETESTING GENERATED NORMAL RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 3.4-20.5 MOL/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.7 AND REPEAT RESULT WAS 4.1. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.4 AND REPEAT RESULT WAS 3.8. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.4 AND REPEAT RESULT WAS 3.7. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866607 ↗
• MalfunctionDec 19, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CO2/BICARB GENERATED FROM ARCHITECT WHEN COMPARED TO A VENOUS BLOOD GAS RESULT. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, A PATIENT THAT WAS REPORTEDLY EXTREMELY LIPEMIC (NO VALUE PROVIDED) HAD A CO2 OF 8.9 MMOL/L (SAMPLE ID: (B)(6)). THE PATIENT'S PHYSICIAN QUESTIONED THE RESULT SINCE IT DIDN'T MATCH THE PATIENT'S CLINICAL PRESENTATION. ANOTHER SAMPLE WAS OBTAINED (SAMPLE ID: (B)(6)) AND GENERATED A RESULT OF 8.8 MMOL/L. 1:2 DILUTION TESTING GENERATED RESUTLS OF < 10.1 AND < 10.1 MMOL/L (CUSTOMER REFERENCE RANGE: 20-29 MMOL/L). A VENOUS BLOOD GAS WAS OBTAINED AND SHOWED A PCO2 OF 38 MMHG (REPORTEDLY NORMAL PER CUSTOMER). IT WAS CONFIRMED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT RELATED TO THE FALSELY DECREASED CO2 RESULT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848081 ↗
• MalfunctionDec 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR A 57-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED PATIENT NORMAL RANGE: 8.4-10.5 MG/DL, PATIENT CRITICAL LOW= <6.0 MG/DL, PATIENT CRITICAL HIGH= >13.0 MG/DL) ON (B)(6) 2025 SID (B)(6) INITIAL RESULT = 5.9 MG/DL, THE EMERGENCY ROOM DREW ANOTHER SAMPLE SHORTLY AFTER AS A POINT OF CARE AND THEY GOT A NORMAL RESULT. (NO SPECIFIC RESULT PROVIDED) ON (B)(6) 2025 REPEAT RESULT OF SAME SAMPLE ON ANOTHER ARCHITECT (B)(6) = 9.6 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716474 ↗
• MalfunctionNov 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED GLUCOSE RESULTS GENERATED FROM THE ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE INITIAL TEST RESULT WAS 11.89 MMOL/L (214.2102 MG/DL), WHICH WAS REPORTED TO THE CLINICAL PHYSICIAN. THE RETEST RESULTS WERE 6.30 AND 6.07 MMOL/L (109.3571 MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525791 ↗
• MalfunctionNov 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT INSULIN AND PROVIDED THE FOLLOWING DATA FOR A 49-YEAR-OLD FEMALE PATIENT: ON (B)(6) 2025 SAMPLE ID (B)(6) RESULT WAS >300 U/ML. THE NEXT DAY 1:2 DILUTION RESULT WAS >600 U/ML. THE SAMPLE WAS SENT TO ANOTHER TESTING CENTER, AND GENERATED A RESULT OF 18.10 U/ML. 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 23500769 ↗
• MalfunctionAug 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS FOR ONE SAMPLE. THE CUSTOMER STATED THAT THERE WAS INSTRUMENT ERROR MESSAGE ¿1051 UNABLE TO CALCULATE RESULT, ABSORBANCE EXCEEDED OPTICAL LIMITS¿ AND THE INSTRUMENT WHEN TO AUTO-DILUTION AND THE RESULT WAS REPORTED OUT OF THE LAB. THE FOLLOWING RESULT WAS PROVIDED: TOTAL BILIRUBIN: AUTO-DILUTION RESULT THAT WAS REPORTED OUT WAS <0.1 MG/DL, RERUN WAS 0.5 MG/DL (REFERENCE RANGE: 0.1-1.2 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715709 ↗
• MalfunctionJul 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT 3.53 MMOL/L, REPEATED 2.21 MMOL/L, A NEW SAMPLE WAS OBTAINED THE NEXT DAY AND THE RESULT WAS 2.19 MML/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675417 ↗
• MalfunctionJul 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CARBON DIOXIDE RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 9.2 MMOL/L, REPEAT = 9.9 MMOL/L, VITROS RESULT = 18 MMOL/L, RADIOMETER RESULT = 23 MMOL/L. THE CUSTOMER INDICATED THE SAMPLE IS LIPEMIC. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553539 ↗
• MalfunctionJul 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CARBON DIOXIDE RESULTS FOR ONE FEMALE PATIENT. THE PATIENT¿S SAMPLES ARE HIGHER BY THE BLOOD GAS ANALYZER (GEM). THE CUSTOMER PROVIDED THE FOLLOWING DATA: ALL SAMPLES ARE FROM THE SAME PATIENT TESTED ON DIFFERENT DAYS: (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 15. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 10. SID (B)(6) GEM RESULT = 33. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 7. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 5. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = <5. SID (B)(6) GEM RESULT = 33. (B)(6) 2025: SID (B)(6) NO RESULTS PROVIDED. SID (B)(6) GEM RESULT = 36. HISTORICAL DATA: (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 25. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 26. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 26. SID (B)(6) GEM RESULT = 32. (B)(6) 2025: SID (B)(6) ARCHITECT RESULT = 24. NORMAL REFERENCE RANGE IS 22-32 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420267 ↗
• MalfunctionJun 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE RESULTS PROCESSED ON THE ARCHITECT C16000 PROCESSING MODULE. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULTS ARE HIGHER. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR ONE PATIENT: INITIAL RESULT = 8.6438 MMOL/L REPEAT RESULT = 24.7098 MMOL/L. NORMAL REFERENCE RANGE IS 22-29 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299500 ↗
• MalfunctionJun 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS FOR A 5-YEAR-OLD KIDNEY TRANSPLANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL CREATININE RESULT WAS 9.04 MG/DL, REPEATED 0.52 AND 0.56 MG/DL (CREATININE NORMAL RANGE 0.57-1.11 MG/DL). SPECIMEN INTEGRITY: SAMPLE SEEMED VISCOUS. THE CUSTOMER STATED THE PATIENT WAS SENT TO ER DUE TO DISCREPANT CREATININE AND THE REDRAW IN THE ER WAS NORMAL. THERE WAS NO KNOWN TREATMENT GIVEN IN THE ER. REDRAW SID (B)(6), (B)(6) 2025 CREATININE RESULT 0.61 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213038 ↗
• MalfunctionJun 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULT GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. THE SAME SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL CALCIUM RESULT = 15.40 MG/DL; REPEAT RESULT = 9.29 MG/DL. PER THE CALCIUM REAGENT PACKAGE INSERT, THE REFERENCE RANGE FOR ADULT IS 8.4 TO 10.2 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201298 ↗

Other Abbott GmbH products

• Alinity37 models · 521 reports · 3 recalls