ARCHITECTRecalls & reported problems across all models

We found 51 models of ARCHITECT by Abbott Laboratories in the FDA's device registry (GUDID). Together they are named in 5,426 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Sep 30, 2026 — classified as 2 deaths, 66 injuries, 5,358 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2,020 reports).

11 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, 2025Class IIOpen, 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-1844-2025 · Root cause: Storage · Recall details · FDA record ↗

2. Oct 19, 2023Class IIOpen, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0682-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

3. Sep 29, 2023Class IIOpen, Classified

   A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

   Z-0325-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

4. Jul 26, 2022Class IIOpen, Classified

   One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

   Z-1660-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Sep 29, 2021Class IIOpen, Classified

   Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

   Z-0272-2022 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

6. Sep 29, 2021Class IIOpen, Classified

   Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

   Z-0271-2022 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗

7. May 24, 2019Class IIITerminated

   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 ↗

8. May 24, 2019Class IIITerminated

   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 ↗

9. Jan 2, 2019Class IITerminated

   Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.

   Z-0971-2019 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

10. Aug 28, 2018Class IITerminated

    There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

    Z-1296-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Jul 18, 2018Class IITerminated

    The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

    Z-1075-2019 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported ARCHITECT problems

ARCHITECT models

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

• ARCHITECT 7D63-21

  NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
  1 recall1,435 reports
• ARCHITECT 3L77-01

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  2 recalls1 death694 reports
• ARCHITECT 3M74-02

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall650 reports
• ARCHITECT 2P24-40

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall1 death646 reports
• ARCHITECT 2K41-27

  CALIBRATOR, SECONDARY
  1 recall374 reports
• ARCHITECT 1G06-11

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  395 reports
• ARCHITECT 1L86-01

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall233 reports
• ARCHITECT 2P24-01

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  2 recalls171 reports
• ARCHITECT 1L86-40

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  169 reports
• ARCHITECT 8K28-02

  CALIBRATOR, SECONDARY
  1 recall115 reports
• ARCHITECT 2K41-37

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  95 reports
• ARCHITECT 7D70-21

  PHOTOMETRIC METHOD, MAGNESIUM
  1 recall37 reports
• ARCHITECT 7D70-31

  PHOTOMETRIC METHOD, MAGNESIUM
  1 recall16 reports
• ARCHITECT 9D28-03

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall15 reports
• ARCHITECT 8K28-11

  CALIBRATOR, SECONDARY
  1 recall2 reports
• ARCHITECT 2P56-21

  NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
  51 reports
• ARCHITECT 2K48-25

  RADIOASSAY, TRIIODOTHYRONINE UPTAKE
  1 recall0 reports
• ARCHITECT 6K95-30

  Photometric method, iron (non-heme)
  1 recall0 reports
• ARCHITECT 6K95-41

  Photometric method, iron (non-heme)
  1 recall0 reports
• ARCHITECT 6L45-21

  DIAZO COLORIMETRY, BILIRUBIN
  46 reports
• ARCHITECT 3L81-22

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  31 reports
• ARCHITECT 3L79-21

  AZO DYE, CALCIUM
  30 reports
• ARCHITECT 3L79-31

  AZO DYE, CALCIUM
  24 reports
• ARCHITECT 03M7401

  Analyzer, chemistry (photometric, discrete), for clinical use
  22 reports
• ARCHITECT 6L45-41

  DIAZO COLORIMETRY, BILIRUBIN
  18 reports
• ARCHITECT 1L75-25

  CALIBRATORS, DRUG SPECIFIC
  17 reports
• ARCHITECT 06R8620

  Reagent, coronavirus serological
  16 reports
• ARCHITECT 3L81-32

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  15 reports
• ARCHITECT 01L8684

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  15 reports
• ARCHITECT 3L80-21

  ENZYMATIC, CARBON-DIOXIDE
  14 reports
• ARCHITECT 3L82-21

  HEXOKINASE, GLUCOSE
  14 reports
• ARCHITECT 3L80-31

  ENZYMATIC, CARBON-DIOXIDE
  12 reports
• ARCHITECT 3M74-98

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  12 reports
• ARCHITECT 03M7484

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  11 reports
• ARCHITECT 6E44-21

  RADIOIMMUNOASSAY, VANCOMYCIN
  5 reports
• ARCHITECT 01G06-01

  Analyzer, chemistry (photometric, discrete), for clinical use
  4 reports
• ARCHITECT 9P18-21

  ACID, LACTIC, ENZYMATIC METHOD
  4 reports
• ARCHITECT 06R8630

  Reagent, coronavirus serological
  3 reports
• ARCHITECT 3L82-41

  HEXOKINASE, GLUCOSE
  2 reports
• ARCHITECT 8K41-27

  RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
  2 reports
• ARCHITECT 1L75-55

  CALIBRATORS, DRUG SPECIFIC
  1 report
• ARCHITECT 1P32-25

  ENZYME IMMUNOASSAY, DIGOXIN
  1 report
• ARCHITECT 1P35-25

  CALIBRATORS, DRUG SPECIFIC
  1 report
• ARCHITECT 2K45-20

  TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
  1 report
• ARCHITECT 7D71-22

  Phosphomolybdate (colorimetric), inorganic phosphorus
  1 report
• ARCHITECT 7D71-31

  Phosphomolybdate (colorimetric), inorganic phosphorus
  1 report
• ARCHITECT 8L92-21

  NADH OXIDATION/NAD REDUCTION, ALT/SGPT
  1 report
• ARCHITECT 8L92-41

  NADH OXIDATION/NAD REDUCTION, ALT/SGPT
  1 report
• ARCHITECT 9D96-21

  COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL
  1 report
• ARCHITECT 5P04-01

  CALIBRATOR, MULTI-ANALYTE MIXTURE
  1 report
• ARCHITECT 2K91-29

  CALIBRATOR, SECONDARY
  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 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952658 ↗
• MalfunctionSep 30, 2026Low Test Results

  The customer observed a falsely decreased Calcium result generated on the ARCHITECT c4000 Processing Module for one sample. The following results were provided:(Customer provided Calcium reference range: 8.1-10.0 mg/dL).SID (b)(6), 74-year-old female patient:Calcium result = 5.8 mmol/L, repeat result = 9.2 mg/dL. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947903 ↗
• MalfunctionSep 30, 2026High Test Results

  The customer observed falsely elevated Creatinine results generated on the ARCHITECT c4000 instrument for a. The following data was provided:(Patient normal ranges: Adult Male 0.73-1.18 mg/dL, Adult Female 0.55-1.02 mg/dL)Patient 1(b)(6) 2026, 22-year-old femaleSID (b)(6) initial result 5.87 mg/dL (on (b)(6) repeated 0.73 and 0.69 mg/dL (the patient sample was sent to a sister hospital and repeated on two separate Alinity c analyzers).The patient was sent to emergency room at sister hospital, and a sample was drawn that yielded normal results. The patient did not receive any treatment.Patient 2(b)(6) 2026, 29-year-old femaleSID (b)(6) initial result 2.02 mg/dL (on (b)(6), repeated 0.61 and 0.57 mg/dL (patient sample was sent to a sister hospital and repeated on two separate Alinity c analyzers) No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944582 ↗
• MalfunctionSep 29, 2026High Test Results

  The customer reported a falsely elevated potassium result generated on the ARCHITCT c16000 Processing Module for a 71 year old male patient with liver cirrhosis. The following data was provided:SID (b)(6): initial result = 7.29 mmol/L, repeats after re-centrifugation = 4.67 mmol/L and 4.66 mmol/LThe discrepant result was not reported out of the laboratory. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932831 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931652 ↗
• MalfunctionSep 23, 2026Low Test Results

  The customer observed falsely depressed Sodium results on the ARCHITECT c16000 Processing Module for one patient. The following results were provided:SID: (b)(6), initial Sodium result= 115.4 mmol/L; repeat result on AU5800 platform= 136 mmol/L; repeat on ARCHITECT after recalibration= 137.6 mmol/L.Reference ranges:Abbott system: 136 - 145 mmol/L,Au5800: 135-145 mmol/L.There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869034 ↗
• MalfunctionSep 14, 2026Thermal Decomposition of Device

  The customer observed error 3598 when processing on the ARCHITECT c4000 Processing Module. Further troubleshooting was performed and found cpu11 to cnn5 cable have burnt mark. There was no impact to patient management or user safety.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753451 ↗
• MalfunctionSep 11, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735101 ↗
• MalfunctionSep 9, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697671 ↗
• MalfunctionSep 9, 2026Imprecise or Erratic Results

  The customer observed imprecise ARCHITECT Sirolimus results generated on the ARCHITECT i1000SR Processing Module for one sample.The following results were provided:Initial result = 16.53 ng/mL, repeat result = 10.33 ng/mL, sample repeated two times = 12.41 ng/mL, 12.11 ng/mL (customer believes the repeated results are correct) No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688992 ↗
• MalfunctionSep 9, 2026False Negative Result

  The customer observed a false negative ARCHITECT Anti-HCV result generated on the ARCHITECT i2000SR Processing Module for an elderly patient that was recently diagnosed with HCV.ARCHITECT result = negative, a positive test strip result, and a positive result when retested result on another ARCHITECT. (no specific results provided). No impact on patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688451 ↗
• MalfunctionAug 24, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409467 ↗
• MalfunctionAug 14, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254092 ↗
• MalfunctionAug 13, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50239382 ↗
• MalfunctionJul 2, 2026Thermal Decomposition of Device; Fire; Sparking

  The customer observed a burning smell, smoke and visible flame near the induction heater inside the ARCHITECT i2000SR Processing Module. The customer stated error "5900 Step loss detected in (reagent inner carousel motor). / (b)(6) 2026 / 15:57:52" was generated just as the ARCHITECT i2000SR Processing Module stopped.The customer stated there was a burning smell and smoke, followed by a visible flame near the induction heater.The fire had been extinguished and there were no injuries or other damage.The fire was contained within the unit. The smoke spread outside the unit, and the odor spread throughout the lab.Service inspected the cables around the induction heater, RV loader and STAT pipettor, and confirmed that they were normal. The control module, induction heater part was damaged with black soot deposits and was replaced. Additionally, the sample probe was replaced, pipettor calibrated, and probe/wash stations were cleaned. Normal operation and absence of errors confirmed via start-up and induction heater checks. Control measurements were taken, generating normal range results, and the system was operating normally. No injury was reported.Update: Clarification was provided on

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700250 ↗

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