ARCHITECT 1L86-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00380740001537), received between Aug 12, 2016 and Sep 9, 2026 — classified as 11 injuries, 222 malfunctions.

The most frequently reported specific device problem is “High Test Results” (67 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 29, 2021Open, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 13, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED CUTOFF IS <15.6 PG/ML): (B)(6) 2026, SID (B)(6): INITIAL RESULT = 55.6 PG/ML, REPEAT = 2.4 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857880 ↗
• MalfunctionMar 31, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TROPONIN RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR A MALE PATIENT. PID (B)(6), INITIAL RESULT = 268.3 PG/ML, REPEAT RESULT = 8.6 PG/ML, REPEAT RESULT (PID (B)(6) = 9.2 PG/ML AND 9.6 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740888 ↗
• MalfunctionMar 30, 2026Leak/Splash

  THE CUSTOMER REPORTED WHILE TRYING TO REMOVE THE SEPTUMS ON THE ARCHITECT I1000SR PROCESSING MODULE, LIQUID FROM THE SURFACE OF THE PROBE CONDITIONING SOLUTION BOTTLE SURFACE SPLASHED ON THEIR FACE. THE CUSTOMER IMMEDIATELY WASHED HER FACE IMMEDIATELY AND NO RASH OR SKIN IRRITATION WAS OBSERVED. THE CUSTOMER REPORTED ONLY GLOVES WERE BEING WORN AT THE TIME, NO MASK. NO MEDICAL INTERVENTION WAS REQUIRED. NO IMPACT TO PATIENT MANAGEMENT OR FURTHER IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712252 ↗
• MalfunctionMar 17, 2026Smoking

  THE SMOKE COMING OUT FROM ARCHITECT I1000SR PROCESSING MODULE POWER SUPPLY WHEN THE THIRD-PARTY DISTRIBUTOR ENGINEER ONSITE FOR TSH ASSAY UPDATE. THE THIRD-PARTY DISTRIBUTOR ENGINEER STATED THAT LOUD NOISE COMING FROM THE ARCHITECT I1000SR PROCESSING MODULE, AND SMOKE WAS OBSERVED. THE SMOKE FROM POWER SUPPLY CONNECTED TO ARCHITECT I1000SR PROCESSING MODULE. THERE WAS NO DAMAGE TO THE CUSTOMER FACILITY. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED. NO ADDITIONAL IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619797 ↗
• InjuryMar 16, 2026Use of Device Problem

  WHILE REPLACING PARTS ON THE I1000SR PROCESSING MODULE, THE FIELD SERVICE ENGINEER (FSE) SUSTAINED A 2-INCH CUT ON HIS LOWER RIGHT PALM. CUT ALLOWED TO BLEED AND WASHED WITH SOAP AND WATER. DID NOT REQUIRE STITCHES. CURRENTLY BANDAGED AND HEALING. THE FIELD SERVICE ENGINEER (FSE) NOTIFIED OCCUPATIONAL HEALTH AND WENT TO HIS PCP AND IS BEING TESTED FOR BLOODBORNE DISEASES HIV AND HEPATITIS A/B/C AS WELL AS TETANUS. HE WILL BE TESTED AGAIN IN ONE MONTH AND THREE MONTHS TO CONFIRM IMMUNE STATUS. AS A PRECAUTION, HE IS BEING PRESCRIBED WITH PROPHYLAXIS. THE INDIVIDUAL WAS STARTED ON PROPHYLAXIS.

  Patient problems: Laceration(s)

  MAUDE report 24604820 ↗
• MalfunctionMar 3, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT INTACT PTH RESULT GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR A 79-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6): INITIAL INTACT PTH RESULT = 112.2 PG/ML THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND PERFORMED ON AN ALINITY PLATFORM = 37.50 PG/ML NORMAL RANGE = 6.7-38.8 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501223 ↗
• MalfunctionDec 18, 2025Smoking; Smoking

  THE CUSTOMER OBSERVED VISIBLE SMOKE FROM A CABLE ON THE ARCHITECT I1000SR INSTRUMENT AND INSTRUMENT ERROR MESSAGE ¿5503 STEP LOSS DETECTED ON (TRIGGER PUMP), ACTUAL (EXPECTED)¿. THERE WAS NO REPORTED IMPACT TO USER SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837762 ↗
• MalfunctionNov 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH RESULTS GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR THREE PATIENTS. THE SAMPLES WERE SENT OUT TO LABCORP, YIELDING HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: NORMAL RANGE FOR TSH: 0.350 TO 4.940 IU/ML PATIENT 1 (31-YEAR-OLD, FEMALE): ARCHITECT TSH RESULT = 0.3224 IU/ML; LABCORP. RESULT = 1.930 IU/ML. PATIENT 2 (45-YEAR-OLD, FEMALE): ARCHITECT TSH RESULT = 0.3113 IU/ML; LABCORP. RESULT = 1.84 IU/ML. PATIENT 3 (55-YEAR-OLD, FEMALE): ARCHITECT TSH RESULT = 0.088 IU/ML; LABCORP. RESULT = 0.703 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463924 ↗
• MalfunctionOct 30, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A 22-YEAR-OLD FEMALE WHO UNDERWENT A GYNECOLOGICAL EXAMINATION. THE INITIAL HCG RESULT WAS 245.25 MIU/ML (REFERENCE RANGE: < 5 MIU/ML). THE CUSTOMER RETESTED THE SAMPLE TWICE AND GENERATED BOTH RESULTS OF < 1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426735 ↗
• MalfunctionOct 27, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT TOXO IGM AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) INITIAL RESULT WAS 5.07 (REACTIVE) AND REPEAT RESULTS WERE 0.05 (NON-REACTIVE) AND 0.05 (NON-REACTIVE). 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 23390024 ↗
• MalfunctionOct 22, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED MULTIPLE ERROR CODES (1005 UNABLE TO CALCULATE RESULT. RLU OUTSIDE LOWEST CAL, 1007 ERROR DURING ACTIVATED MEASUREMENT, 1011 ERROR DURING FOREGROUND MEASUREMENT) FOLLOWED BY A FALSE NEGATIVE HIV RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR ONE PATIENT. SID V040527 INITIAL RESULT = NEGATIVE, REPEAT RESULT ON ANOTHER ARCHITECT = POSITIVE, NO ACTUAL RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359738 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER STATED THAT THERE WAS AN ERROR MESSAGE ON THE ARCHITECT I1000SR INSTRUMENT FOR A REAGENT CAROUSEL ERROR. WHILE PERFORMING TROUBLESHOOTING AND LOOKING AT THE GAPS IN THE RSM, LIQUID SPLASHED ON THE CUSTOMER¿S FACE. THE CUSTOMER WAS WEARING GLOVES AND GLASSES. THE CUSTOMER WASHED WITH WATER AND DID NOT REQUIRE ANY TREATMENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304502 ↗
• MalfunctionOct 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT TOXO IGG RESULT FOR ONE PATIENT WITH A HISTORY OF BEING NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6) (FEMALE PATIENT): INITIAL RESULT = 143 IU/ML (REACTIVE), REPEAT = NONREACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232672 ↗
• InjuryOct 2, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED AN ISSUE WITH THE ARCHITECT I1000SR ANALYZER. THE BUFFER BOTTLE SENSOR WAS NOT BEING DETECTED BY THE INSTRUMENT; THEREFORE, THE INSTRUMENT WENT INTO STOP MODE. THE FIELD SERVICE ENGINEER ARRIVED ONSITE AND WHILE INSPECTING THE FLUIDICS BOARD, THE HC PERISTALTIC TUBING CAME LOOSE AND SPLASHED FLUID ONTO THE SKIN OF THE FSE¿S FACE. THE FSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. AFTER THE INCIDENT, THE FSE IMMEDIATELY PROCEEDED TO WASH THEIR FACE WITH SOAP AND WATER. AFTER COMPLETING THE SERVICE CALL, THE FSE NOTIFIED THE OCCUPATIONAL RISK INSURER (ART) AND RECEIVED THE FOLLOWING INSTRUCTIONS. THE FSE WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2025, AT 1:00 PM TO HAVE BLOOD DRAWN AND TO START LISOTYR AND DOLUFEVIR (ANTI-RETROVIRAL MEDICATION). THE FSE IS DOING FINE AND IS STILL WORKING WHILE TAKING THE MEDICATION. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23199182 ↗
• MalfunctionSep 30, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED FOR A 20-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 21-73 PG/ML): SAMPLE ID (B)(6), INITIAL RESULT = 6000 PG/ML, REPEAT RESULT = 5800 PG/ML. 2 HOURS LATER A NEW SAMPLE WAS OBTAINED AND RESULT = 0.4 PG/ML FIRST SAMPLE ALSO REPEATED AT THIS TIME AND RESULT = 0.4 PG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23179447 ↗
• MalfunctionAug 20, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED WHEN SHE REMOVED THE WASTE TANK OF THE ARCHITECT I1000SR PROCESSING MODULE TO EMPTY IT AND OPENED THE SPOUT, SHE STATES SHE FELT A DROP ON HER LIP. SHE WIPED IT AWAY, SPIT, AND GARGLED WITH MOUTHWASH. SHE STATED IT WAS NOT IN HER MOUTH AND JUST ON HER LIP; BUT DID THOSE PRECAUTIONS ANYWAY. THE CUSTOMER REPORTED SHE WAS WEARING A LABORATORY COAT, GLOVES, BUT NO MASK. NO IMPACT TO PATIENT MANAGEMENT OR FURTHER IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848783 ↗
• InjuryJul 28, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED BEING SPLASHED IN THE RIGHT EYE WITH THE WASH BUFFER WHILE PREPARING THE WASH BUFFER SOLUTION FOR THE ARCHITECT I1000SR PROCESSING MODULE. SHE RINSED HER EYES WITH WATER FOR ONE MINUTE. HER EYES APPEARED RED FOLLOWING THE INCIDENT. THE CUSTOMER SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TOBRADEX EYE DROPS. NO FURTHER REDNESS WAS OBSERVED AFTER TREATMENT. IT WAS NOTED THAT THE CUSTOMER WAS WEARING GLOVES BUT WAS NOT WEARING PROTECTIVE GOGGLES AT THE TIME OF THE INCIDENT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Red Eye(s)

  MAUDE report 22631717 ↗
• MalfunctionJun 27, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT RHTLV-I/II RESULTS FOR ONE PATIENT SAMPLE GENERATED ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RHTLV I/II RESULT = 3.21 S/CO; REPEAT RESULTS = 0.25 / 1.52 / 0.21 S/CO (REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346463 ↗
• MalfunctionMay 29, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER SMELLED SMOKE COMING FROM THE ARCHITECT I1000SR. THE INSTRUMENT STOPPED WORKING AND THE CUSTOMER TRACED THE SMOKE SMELL TO THE BACK OF THE COMPUTER. NO SMOKE WAS OBSERVED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110564 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WAS CLEANING THE MANIFOLD NOZZLE OF THE WASH STATION ON THE ARCHITECT I1000SR MODULE USING A BLOOD COLLECTION NEEDLE. AFTER THE USE OF THE BLOOD COLLECTION NEEDLE, THE CUSTOMER PLACED THE NEEDLE INTO THE PROTECTIVE CAP AND THE NEEDLE POPPED OUT THROUGH THE CAP AND STUCK THE CUSTOMER¿S FINGER. THE CUSTOMER WAS PROSCRIBED RETROVIRAL MEDICATION TO BE TAKEN AFTER MEALS. THERE WAS NO ADDITIONAL HARM TO THE USER REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22079157 ↗
• MalfunctionMay 14, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL HCG RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR THREE PATIENTS. THE SAMPLES WERE REPEATED, AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED (= 5.00 MIU/ML IS NEGATIVE, >5.00 TO <25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 31.32 MIU/ML (POSITIVE). ON (B)(6) 2023 REPEAT RESULT = < 1.20 MIU/ML (NEGATIVE). SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 2.99 MIU/ML (NEGATIVE). ON (B)(6) 2025 REPEAT RESULTS = 30.03 MIU/ML (POSITIVE), 7.69 MIU/ML (GRAYZONE), < 1.20 MIU/ML (NEGATIVE). SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 47.48 MIU/ML (POSITIVE). ON (B)(6) 2025 REPEAT RESULTS = 19.05 MIU/ML (POSITIVE), < 1.20 MIU/ML (NEGATIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017896 ↗
• MalfunctionApr 24, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HIV AG/AB COMBO FOR ONE PATIENT AND QUALITY CONTROLS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <1. NON-REACTIVE; >1, REACTIVE): INITIAL RESULT= 0.82 S/CO; REPEAT RESULT (NEW REAGENT KIT)= 1.20 S/CO . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901674 ↗
• MalfunctionMar 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 179.6 PG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN, REPEAT RESULT WAS <1.9 PG/ML. SAMPLE ID (B)(6) INITIAL RESULT WAS 52.2, REPEAT RESULT WAS <1.9 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734159 ↗
• MalfunctionMar 19, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS THAT NEGATIVE ON OTHER METHODS. THE RESULTS PROVIDED WERE: PATIENT 1: INITIAL=1.60 S/CO (> OR = 1.00 S/CO=REACTIVE) /REPEATED=1.57 S/CO /ON ARCHITECT I2SR=0.20 S/CO (< 1.00 S/CO=NONREACTIVE) /COLLOIDAL GOLD STANDARD METHOD=NEGATIVE. PATIENT 2: INITIAL=2.19 S/CO /REPEATED=2.21 S/CO /ON ARCHITECT I2SR=0.14 S/CO /COLLOIDAL GOLD STANDARD METHOD=NEGATIVE. PATIENT 3: INITIAL=1.40 S/CO /REPEATED=1.16 S/CO /ON ARCHITECT I2SR=0.17 S/CO /COLLOIDAL GOLD STANDARD METHOD=NEGATIVE. PATIENT 4: INITIAL=2.00 S/CO /REPEATED=2.20 S/CO /ON ARCHITECT I2SR=0.20 S/CO /COLLOIDAL GOLD STANDARD METHOD=NEGATIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642811 ↗