ARCHITECT 03M7401Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380740023386), received between Mar 25, 2024 and Sep 30, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, 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 ↗
• MalfunctionAug 24, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409467 ↗
• 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 ↗
• MalfunctionMar 19, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL PSA RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED:SID UNKNOWN, INITIAL PSA RESULT WAS 6.18, REPEATED 0.11. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640964 ↗
• MalfunctionNov 24, 2025Device Fell; Device Fell

  THE OPERATOR REPORTED THE FRONT COVER OF THE ARCHITECT I2000SR PROCESSING MODULE DROPPED HITTING THE HEAD OF THE OPERATOR. THE OPERATOR RECEIVED BASIC CHECKS IN THE ER AND HAS SINCE RETURNED TO WORK. NO IMPACT TO PATIENT MANAGEMENT OR FURTHER USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634848 ↗
• MalfunctionOct 6, 2025Sparking; Sparking

  THE CUSTOMER OBSERVED SPARKS AND A BURNING SMELL FROM THE X-SYSTEMS CENTRIFUGE SN (B)(6) MODEL # 3531. NO USER SAFETY OR PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220672 ↗
• MalfunctionAug 14, 2025Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE COMING FROM THE ABBOTTLINK FIREWALL ADAPTER ASSOCIATED WITH AN ARCHITECT I2000SR ANALYZER. THE CUSTOMER REPORTED THAT DUE TO A LEAK FROM THE LIQUID WASTE PUMP ON THE ANALYZER, THE ABBOTTLINK FIREWALL ADAPTER WAS SUBMERGED, CAUSING SMOKE AND TRACES OF MELTING ON THE ADAPTER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED. NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808710 ↗
• InjuryJul 22, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED RESIDUE ON THE FLOOR CAUSED BY A WASH BUFFER LEAK FROM THE ARCHITECT I2000 PROCESSING MODULE. THE LEAK WAS CLEANED USING HYDROCHLORIC ACID, AND AS A RESULT, THREE PERSONNEL FAINTED FOR WHAT WAS REPORTED TO BE A SHORT PERIOD OF TIME. THE PERSONNEL WERE TAKEN OUT OF THE LABORATORY AND TREATED IN THE EMERGENCY DEPARTMENT WHERE THEY REGAINED CONSCIOUSNESS AND RECOVERED SHORTLY THEREAFTER. NO PROBLEMS WERE OBSERVED FOLLOWING TREATMENT. DESPITE MULTIPLE ATTEMPTS, WE WERE UNABLE TO OBTAIN ANY INFORMATION REGARDING THE TREATMENT ADMINISTERED. THE WASH BUFFER MSDS DOCUMENT (6C54-58) WAS PREVIOUSLY COMMUNICATED TO THE PERSONNEL, YET THE INSTRUCTIONS WERE NOT FOLLOWED. THE LEAK FROM THE DEVICE HAS BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. THE INDIVIDUALS WERE GRANTED LEAVE TIME DUE TO THE INCIDENT AS A PRECAUTIONARY MEASURE, HOWEVER, HAVE SINCE BEEN RELEASED BACK TO WORK.

  Patient problems: Syncope/Fainting

  MAUDE report 22564589 ↗
• InjuryJul 22, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED RESIDUE ON THE FLOOR CAUSED BY A WASH BUFFER LEAK FROM THE ARCHITECT I2000 PROCESSING MODULE. THE LEAK WAS CLEANED USING HYDROCHLORIC ACID, AND AS A RESULT, THREE PERSONNEL FAINTED FOR WHAT WAS REPORTED TO BE A SHORT PERIOD OF TIME. THE PERSONNEL WERE TAKEN OUT OF THE LABORATORY AND TREATED IN THE EMERGENCY DEPARTMENT WHERE THEY REGAINED CONSCIOUSNESS AND RECOVERED SHORTLY THEREAFTER. NO PROBLEMS WERE OBSERVED FOLLOWING TREATMENT. DESPITE MULTIPLE ATTEMPTS, WE WERE UNABLE TO OBTAIN ANY INFORMATION REGARDING THE TREATMENT ADMINISTERED. THE WASH BUFFER MSDS DOCUMENT (6C54-58) WAS PREVIOUSLY COMMUNICATED TO THE PERSONNEL, YET THE INSTRUCTIONS WERE NOT FOLLOWED. THE LEAK FROM THE DEVICE HAS BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. THE INDIVIDUALS WERE GRANTED LEAVE TIME DUE TO THE INCIDENT AS A PRECAUTIONARY MEASURE, HOWEVER, HAVE SINCE BEEN RELEASED BACK TO WORK.

  Patient problems: Syncope/Fainting

  MAUDE report 22564580 ↗
• InjuryJul 22, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED RESIDUE ON THE FLOOR CAUSED BY A WASH BUFFER LEAK FROM THE ARCHITECT I2000 PROCESSING MODULE. THE LEAK WAS CLEANED USING HYDROCHLORIC ACID, AND AS A RESULT, THREE PERSONNEL FAINTED FOR WHAT WAS REPORTED TO BE A SHORT PERIOD OF TIME. THE PERSONNEL WERE TAKEN OUT OF THE LABORATORY AND TREATED IN THE EMERGENCY DEPARTMENT WHERE THEY REGAINED CONSCIOUSNESS AND RECOVERED SHORTLY THEREAFTER. NO PROBLEMS WERE OBSERVED FOLLOWING TREATMENT. DESPITE MULTIPLE ATTEMPTS, WE WERE UNABLE TO OBTAIN ANY INFORMATION REGARDING THE TREATMENT ADMINISTERED. THE WASH BUFFER MSDS DOCUMENT (6C54-58) WAS PREVIOUSLY COMMUNICATED TO THE PERSONNEL, YET THE INSTRUCTIONS WERE NOT FOLLOWED. THE LEAK FROM THE DEVICE HAS BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. THE INDIVIDUALS WERE GRANTED LEAVE TIME DUE TO THE INCIDENT AS A PRECAUTIONARY MEASURE, HOWEVER, HAVE SINCE BEEN RELEASED BACK TO WORK.

  Patient problems: Syncope/Fainting

  MAUDE report 22564576 ↗
• MalfunctionJul 16, 2025Smoking; Smoking

  THE CUSTOMER OBSERVED WHITE SMOKE COMING OUT FROM THE BACK OF THE INSTRUMENT NEAR THE PUMP STORAGE AREA. THE CUSTOMER TURNED OFF THE POWER AND UNPLUGGED THE INSTRUMENT. THE FSE REPLACED THE VACUUM PUMP. THERE IS NO FURTHER SMOKE OR SMELL COMING FROM THE INSTRUMENT. FSE PERFORMED A VACUUM SYSTEM TEST WHICH PASSED AND CONTROLS IN RANGE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521031 ↗
• MalfunctionApr 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL PSA AND ARCHITECT CA 125 RESULTS FOR PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6), INITIAL TOTAL PSA RESULT, ON (B)(6) 2025, WAS 1.077, REPEAT RESULT WAS 7.590 NG/ML SAMPLE ID (B)(6), INITIAL CA 125 RESULT, ON (B)(6) 2025, WAS 11.2, REPEAT RESULT WAS 39.4 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928869 ↗
• MalfunctionMar 17, 2025Smoking; Smoking

  THE CUSTOMER REPORTED ERROR MESSAGE ERROR CODE 3350, UNABLE TO PROCESS TEST, ASPIRATION ERROR FOR (R2 PIPETTOR) AT (R2 INNER REAGENT) ON THE ARCHITECT I2000 SERIAL NUMBER (B)(6). THE ABBOTT FIELD SERVICE ENGINEER(FSE) AS PART OF TROUBLESHOOTING REPLACED THE R2 PM SENSOR. WHILE REPLACING THE SENSOR, A DROP OF LIQUID ACCIDENTALLY FELL ON THE PM BOARD CAUSING IT TO SMOKE. THE FSE TURNED THE POWER OFF AND REPLACED THE PM SENSOR BOARD. THE FSE THEN TURNED THE POWER BACK ON. THERE IS NO FURTHER SMOKE OR SMELL COMING FROM THE INSTRUMENT. FSE PERFORMED A STARTUP, FLUSH FLUIDS, PM SENSOR TEST FOR ALL LOCATIONS AND LLS TEST FOR ALL LOCATIONS. ALL TESTS PASSED. INSTRUMENT READY FOR USE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURIES TO THE USERS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619948 ↗
• MalfunctionMar 5, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE <5 MIU/ML IS NEGATIVE, >/= 25.00 MIU/ML IS POSITIVE): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 1423.66 MIU/ML, (B)(6) 2025 REPEAT RESULT = <1.20 MIU/ML REPEATED 10 TIMES ON BOTH ARCHITECT ANALYZERS AND OBTAINED ALL NEGATIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524567 ↗
• MalfunctionDec 9, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2024 INITIAL RESULT = 838.9 MIU/ML NEW SAMPLE PROCESSED ON (B)(6) 2024 SID (B)(6) SAME PATIENT = <1.2 MIU/ML SID (B)(6) PRIMARY AND SECONDARY TUBE REPEATED ON (B)(6) 2024 = <1.2 MIU/ML FOR BOTH TUBES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20882489 ↗
• MalfunctionDec 9, 2024Device Fell; Device Fell

  THE CUSTOMER OBSERVED THE TOP COVER OF THE ARCHITECT I2000SR ANALYZER WOULD NOT REMAIN IN THE UPRIGHT POSITION. THE CUSTOMER STATED THAT THERE HAVE BEEN NO INJURIES DUE TO THE COVER NOT STAYING UP. THERE WAS NO INJURY REPORTED AND NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881192 ↗
• MalfunctionNov 26, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HIV AG/AB COMBO FOR MULTIPLE PATIENTS. THE PATIENTS WITH INITIAL REACTIVE HIV RESULTS ARE RECENTRIFUGED AND REPEATED WITH REACTIVE RESULTS. WHEN THE SAME PATIENTS WERE REPEATED ON THE ROCHE COBAS, THE RESULTS WERE NEGATIVE. THERE WERE NO SPECIFIC PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785913 ↗
• MalfunctionNov 12, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT ANTI-HBC II RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT = 0.1, REPEAT RESULT = 5.0. THE CUSTOMER BELIEVES THE REACTIVE RESULT IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667454 ↗
• MalfunctionSep 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED AN ERROR CODE 5394 (INDUCTION HEATING OPERATION FAILED, DEVICE NOT READY) GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND NOTICED A SMELL OF ELECTRICAL BURN NEAR THE HOPPER. UPON FURTHER INSPECTION, THE FSR FOUND BURNT INDUCTION HEATER CONTROLLER. THE FSR REPLACED THE PART TO RESOLVE THE ISSUE. THERE WAS NO INJURY TO THE USER REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277455 ↗
• MalfunctionAug 8, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) SERUM = 4.1 S/CO; EDTA PLASMA = 1.8 S/CO, SIEMENS PLATFORM IS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938630 ↗
• MalfunctionJul 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HAVAB-IGG RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND NONREACTIVE RESULTS WERE OBTAINED. THE CUSTOMER STATED ALL THE RETEST RESULTS WERE FROM THE SAME SAMPLE. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): ON (B)(6) 2024 SID (B)(6) (B)(6) RESULT = 1.08 S/CO (REACTIVE). (B)(6) 2024 SID (B)(6) (B)(6) RESULT = 0.95 S/CO (NON-REACTIVE). (B)(6) 2024 SID (B)(6) (B)(6) RESULT = 0.12 S/CO (NON-REACTIVE). (B)(6) 2024 SID (B)(6) (B)(6) RESULT = 0.12 S/CO (NON-REACTIVE). (B)(6) 2024 SID (B)(6) (B)(6) RESULT = 0.17 S/CO (NON-REACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809718 ↗
• MalfunctionMar 25, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE RESULTS FOR ARCHITECT SYPHILIS TP AND HIV AG/AB COMBO ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6), FOR 4 PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SYPHILIS: SID (B)(6) PROCESSED ON (B)(6) 2024 RESULT = 3.02 S/CO REPEATED AND RESULT UNCHANGED(POSITIVE). NEW COLLECTION SAME PATIENT SID (B)(6) PROCESSED ON (B)(6) 2024 = 0.00 S/CO NEGATIVE SID (B)(6) PROCESSED ON (B)(6) 2024 RESULT = 21.58 S/CO REPEATED AND RESULT UNCHANGED(POSITIVE). NEW COLLECTION SAME PATIENT SAME DAY SID (B)(6) RESULT = 0.09 S/CO NEGATIVE SID (B)(6) PROCESSED ON 28FEB2024 RESULT = 20.49 S/CO REPEATED AND RESULT UNCHANGED(POSITIVE). NEW COLLECTION SAME PATIENT SID (B)(6) PROCESSED ON (B)(6) 2024 = 0.10 S/CO NEGATIVE NEW COLLECTION SAME PATIENT SID (B)(6) PROCESSED ON (B)(6) 2024 = 0.10 S/CO NEGATIVE HIV: SID (B)(6) PROCESSED ON (B)(6) 2024 RESULT = 15.61 S/CO REPEAT RESULT = 17.70 S/CO NEW COLLECTION RESULT = 0.07 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18971082 ↗