ARCHITECTRecalls & reported problems across all models

We found 38 models of ARCHITECT by Abbott Ireland in the FDA's device registry (GUDID). Together they are named in 1,140 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2016 and Sep 29, 2026 — classified as 9 injuries, 1,131 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (370 reports).

4 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-1851-2025 · 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-1850-2025 · 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-1849-2025 · 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-1848-2025 · Root cause: Storage · Recall details · FDA record ↗

Most reported ARCHITECT problems

ARCHITECT models

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

• ARCHITECT 07K6327

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  185 reports
• ARCHITECT 7K78-25

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  176 reports
• ARCHITECT 7K64-25

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  130 reports
• ARCHITECT 7K78-30

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  110 reports
• ARCHITECT 7K63-25

  CALIBRATOR, SECONDARY
  108 reports
• ARCHITECT 7K62-25

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  94 reports
• ARCHITECT 7K62-30

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  58 reports
• ARCHITECT 7K77-25

  RADIOIMMUNOASSAY, PROGESTERONE
  1 recall1 report
• ARCHITECT 7K65-02

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  1 recall0 reports
• ARCHITECT 5P02-02

  CALIBRATOR, SECONDARY
  1 recall0 reports
• ARCHITECT 07K6402

  Calibrator, secondary
  1 recall0 reports
• ARCHITECT 7K65-29

  RADIOIMMUNOASSAY, FREE THYROXINE
  38 reports
• ARCHITECT 7K76-25

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  37 reports
• ARCHITECT 07K6427

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  32 reports
• ARCHITECT 7K62-35

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  25 reports
• ARCHITECT 7K65-34

  RADIOIMMUNOASSAY, FREE THYROXINE
  25 reports
• ARCHITECT 03P6824

  PHOTOMETRIC METHOD, MAGNESIUM
  22 reports
• ARCHITECT 7K72-25

  RADIOIMMUNOASSAY, ESTRADIOL
  14 reports
• ARCHITECT 7K76-35

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  12 reports
• ARCHITECT 07K6432

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  8 reports
• ARCHITECT 07K6332

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  6 reports
• ARCHITECT 03P6834

  PHOTOMETRIC METHOD, MAGNESIUM
  6 reports
• ARCHITECT 7K65-39

  RADIOIMMUNOASSAY, FREE THYROXINE
  5 reports
• ARCHITECT 07K6437

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  5 reports
• ARCHITECT 02R9835

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  5 reports
• ARCHITECT 7K61-37

  RADIOASSAY, VITAMIN B12
  4 reports
• ARCHITECT 7K64-35

  SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  4 reports
• ARCHITECT 7K78-35

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  4 reports
• ARCHITECT 7K72-35

  RADIOIMMUNOASSAY, ESTRADIOL
  4 reports
• ARCHITECT 07K6337

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  4 reports
• ARCHITECT 04S9520

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  4 reports
• ARCHITECT 7K61-27

  RADIOASSAY, VITAMIN B12
  3 reports
• ARCHITECT 7K63-35

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  3 reports
• ARCHITECT 04T0930

  DIAZO COLORIMETRY, BILIRUBIN
  3 reports
• ARCHITECT 02R9825

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  2 reports
• ARCHITECT 7K63-01

  RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
  1 report
• ARCHITECT 7K78-01

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  1 report
• ARCHITECT 04T0920

  BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
  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 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930571 ↗
• MalfunctionSep 28, 2026High Test Results

  A literature review article by Suzuki, T., Ohba, et al. ¿Spuriously Elevated Free Thyroxine Due to Fibrin Interference in a Patient Receiving Apixaban: A Case Report and Literature Review¿ Internal Medicine. 2026; 65(15):2112-2117. DOI: 10.2169/internalmedicine.6473-25, documented a case study of a 79-year-old female patient with a history of chronic thyroiditis and atrial fibrillation, which was being treated with apixaban once a day. Beginning in 2023, mid December, the patient had routine blood testing with falsely elevated ARCHITECT Free T4. The following results were provided:Mid December 2023, Free T4 result (serum)= >5.00 ng/dL.Late December 2023, Free T4 result (serum)= 2.54 ng/dL.Mid February 2024, Free T4 result (serum)= >5.00 ng/dL; repeat result (plasma)= 0.89 ng/dL.Early October 2024, Free T4 result (plasma)= 1.03 ng/dL.Reference range 1.00-1.70 ng/dL.The patient had a cervical ultrasound performed of which showed mild heterogenous, low-echoic internal echoes in the left thyroid lobe. There was no additional impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916310 ↗
• MalfunctionSep 17, 2026Low Test Results

  The customer reported falsely decreased Total Bilirubin2 results generated by the ARCHITECT c4000 Processing Module for an infant patient. The physician questioned the results associated with sample IDs (b)(6) . The following data was provided:Total Bilirubin reference range for infants: 2 to 12 mg/dL (b)(6) 2026 at 10:30 AM SID (b)(6)Total Bilirubin: 11.10 mg/dL.(b)(6) 2026 at 9:53 AM SID (b)(6)Total Bilirubin: 16.6 mg/dL.(b)(6) 2026 at 8:35 PM SID (b)(6)Total Bilirubin: 17.0 mg/dL.(b)(6) 2026 at 10:22 AM SID (b)(6)Total Bilirubin: 8.2 mg/dL.(b)(6) 2026 at 12:11 PM SID (b)(6)Total Bilirubin: 7.30 mg/dL.(b)(6) 2026 at 3:22 PM SID (b)(6)Total Bilirubin: 18.4 mg/dLThis sample was analyzed at another facility using the Alinity platform. (b)(6) 2026 at 11:22 AM SID (b)(6)Total Bilirubin: 19.10 mg/dL(b)(6) 2026 at 11:05 AM SID (b)(6)Total Bilirubin: 17.90 mg/dLResults marked with an asterisk (*) were questioned by the physician. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801169 ↗
• MalfunctionSep 14, 2026High Test Results

  The customer observed falsely elevated Magnesium generated from ARCHITECT analyzer and provided the following data for a 74 year old male:Sample ID: (b)(6) initial results was 2.48 mmol/L and repeat result on an Alinity analyzer was 0.83 mmol/L. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756353 ↗
• MalfunctionSep 9, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693012 ↗
• MalfunctionAug 17, 2026High Test Results

  The customer observed falsely elevated ARCHITECT Free T4 results for a 30-year-old female patient. The following data was provided (Customer¿s normal range is 0.70-1.48 ng/dL):Sample ID 300178100007 initial result, on 30JUL2026, was 1.64, repeat results were 1.43, 1.47, and 1.50 ng/dL. Additional results were provided: Free T3 initial result was 2.47, repeat results were 2.34, 2.39, and 2.41 pg/mL; TSH initial result was 29.74, repeat results were 38.76, 39.09, and 38.74 uIU/mL. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280800 ↗
• MalfunctionJun 23, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED FREE T4 REFERENCE RANGE: 10 - 24 PMOL/L): (B)(6) 2026, SID (B)(6), INITIAL RESULT = 35.3 PMOL/L, REPEAT RESULT = 18.7 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 27.7 PMOL/L, REPEAT RESULT = 14.9 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 28.3 PMOL/L, REPEAT RESULT = 21.8 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 30.4 PMOL/L, REPEAT RESULT = 22.2 PMOL/L; SID (B)(6), INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 22.6 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593903 ↗
• MalfunctionFeb 17, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR TWO FEMALE PATIENTS. THESE RESULTS WERE INCONSISTENT WITH THE RESULTS PRODUCED BY OTHER PLATFORMS. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S NORMAL RANGE FOR WOMEN: 5.18 TO 26.53 NG/ML. PATIENT 1 (42-YEAR-OLD): SAMPLE ID: (B)(6) FIRST BLOOD DRAW: ARCHITECT PROLACTIN RESULT = 27 NG/ML, ROCHE PLATFORM RESULT = 13 NG/ML AND 13 NG/ML. (B)(6) 2025 (SECOND BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 22.91 NG/ML CHEMILUMINESCENCE METHOD = 13 NG/ML. PATIENT¿S HISTORICAL RESULT = 44 NG/ML. PATIENT 2 (47-YEAR-OLD): SAMPLE ID: (B)(6) ON (B)(6) 2025 (FIRST BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 47.39 NG/ML ROCHE PLATFORM RESULT = 16 NG/ML . ON (B)(6) 2025 (SECOND BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 48.42 NG/ML, CHEMILUMINESCENCE METHOD = 13 NG/ML, MAGLUMI PLATFORM RESULT = 15 NG/ML. PATIENT¿S HISTORICAL RESULT = 44 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367656 ↗
• 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 29, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN2 RESULTS FOR A 48-HOUR OLD NEWBORN PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA PROVIDED. INITIAL RESULT =18.6 MG/DL, REPEAT RESULTS FROM ROCHE (SEVGI HOSPITAL) =14.6 MG/DL, ROCHE (TRAINING AND RESEARCH HOSPITAL) =15.7MG/DL. REFERENCE RANGE: ABBOTT; 0¿8MG/DL (24 HRS.), 0¿12MG/DL (48 HRS.). REFERENCE RANGE; ROCHE; 0¿8 MG/DL (24 HRS.), 0¿13 MG/DL (48 HRS.). PHYSICIAN ONLY QUESTION RESULTS FOR TOTAL BILIRUBIN. ADDITIONAL DIRECT BILIRUBIN RESULTS PROVIDED. INITIAL RESULT 0.68, REPEAT RESULT (ROCHE) 1.32. REFERENCE RANGE: 0¿0.5 ABBOTT AND 0¿0.58 FROM ROCHE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208456 ↗
• MalfunctionJan 26, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: FT4 2.10 NG/DL. OTHER RESULTS = FT3 2.75 PG/ML TSH 3.16 UIU/ML. PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): FT4 0.97 NG/DL. OTHER RESULTS = FT3 2.60 PG/ML TSH 7.10 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180122 ↗
• MalfunctionJan 26, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT TSH RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: TSH 3.16 UIU/ML OTHER RESULTS = FT3 2.75 PG/ML FT4 2.10 NG/DL. PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): TSH 7.10 UIU/ML OTHER RESULTS = FT3 2.60 PG/ML FT4 0.97 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180089 ↗
• MalfunctionJan 19, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT PROLACTIN RESULTS FOR ONE FEMALE PATIENT. THE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: ARCHITECT INITIAL PROLACTIN RESULT PROCESSED ON (B)(6) 2026 = <12.6 MIU/L REPEAT RESULT = 210 MIU/L SAMPLE SENT TO ANOTHER LABORATORY (METHOD UNKNOWN) RESULT = >200 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24110235 ↗
• 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 ↗
• MalfunctionJan 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE2 RESULTS GENERATED BY THE ARCHITECT C8000 PROCESSING MODULE FOR A PATIENT. A NEW BLOOD SAMPLE WAS DRAWN AND YIELD A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: NORMAL REFERENCE RANGES: CREATININE2: 0.60 TO 1.30 MG/DL. SID (B)(6): 29DEC2025 CREATININE2 INITIAL RESULT = 7.84 MG/DL, REPEAT RESULTS ((B)(6) 2025) = 2.67 AND 2.69 MG/DL. SID (B)(6) (NEW BLOOD DRAW FOR THE SAME PATIENT): (B)(6) 2025 CREATININE2 RESULT = 0.68 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019256 ↗

Other Abbott Ireland products

• Alinity22 models · 643 reports · 7 recalls