ARCHITECT 3M74-98Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740068851), received between Aug 1, 2016 and Oct 8, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED A BURNING SMELL EMANATING FROM THE ARCHITECT I2000SR ANALYZER. UPON INSPECTION BY ABBOTT FIELD SERVICE, BURN MARKS WERE FOUND ON THE ANTENNA BOARD OF THE SAMPLE HANDLER FOR STAT PIPETTORS. NO IMPACT TO USER SAFETY OR PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23242884 ↗
• MalfunctionJul 5, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT SARS-COV-2 IGG RESULT FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2023 SID (B)(6): INITIAL SARS-COV-2 IGG RESULT = 2.58 INDEX; REPEAT RESULT = 0.54 INDEX (REFERENCE RANGE: < 1.4 INDEX IS NEGATIVE, >/= 1.4 INDEX IS POSITIVE) THE CUSTOMER STATED QC FOR SARS-COV-2 IGG WAS WITHIN RANGE. THE CUSTOMER ALSO STATED THE QC WAS OUT OF RANGE FOR THEIR COV-2 IGG II NEGATIVE CONTROL HOWEVER WHEN REPEATED WAS WITHIN RANGE (INITIAL = 656 AU/ML; REPEAT = 5.8 AU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263511 ↗
• MalfunctionMar 5, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NEGATIVE SARS-COV-2 IGG RESULT FOR ONE PATIENT ON AN ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (<1.4 INDEX IS NEGATIVE, >/=1.4 INDEX IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2021, WAS 2.16, REPEATS WERE 0.52 AND 2.02 INDEX. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426234 ↗
• MalfunctionJul 23, 2020Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE AND A BURNING SMELL COMING FROM THE SCC POWER SUPPLY OF THE ARCHITECT I2000SR WHEN TRYING TO POWER ON THE INSTRUMENT MULTIPLE TIMES. THE SMOKE WENT AWAY WHEN THE POWER WAS TURNED OFF. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10317233 ↗
• MalfunctionNov 5, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THAT THE SCC SCREEN WENT BLACK AND WOULD NOT RESTART. THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE ARCHITECT ANALYZER. THERE WAS NO VISIBLE FIRE OR SMOKE OBSERVED. THE CUSTOMER FOUND THAT THE SCC POWER SUPPLY HAS A BURN MARK ON IT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038045 ↗
• MalfunctionApr 24, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE B-HCG RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 66.7, REPEATED ON THIS INSTRUMENT AND ANOTHER INSTRUMENT, BOTH RESULTS CAME OUT AS < 2.0 RESULT UNIT IS MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6516587 ↗
• MalfunctionNov 16, 2016Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE FROM THE ARCHITECT I2000SR ANALYZER SYSTEM CONTROL CENTER (SCC). THE CUSTOMER STATED THAT THEY SMELLED SMOKE, AND WHEN THEY OPENED THE DOOR WHERE THE SCC IS LOCATED, THEY SAW VISIBLE SMOKE COMING FROM THE REAR OF THE SCC. NO FIRE OR OTHER VISIBLE DAMAGE WAS SEEN. THE ANALYZER AND THE SCC WERE POWERED OFF. NO FIRE OR INJURY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6107261 ↗
• MalfunctionAug 17, 2016Fluid/Blood Leak; Fluid/Blood Leak

  FIELD SERVICE REPLACED THE INCORRECT TUBING ON THE ARCHITECT I2000SR ANALYZER PER THE MANDATORY TECHNICAL SERVICE BULLETIN. THERE WAS NO IMPACT TO PATIENT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5884522 ↗
• MalfunctionAug 17, 2016Fluid/Blood Leak; Fluid/Blood Leak

  FIELD SERVICE REPLACED THE INCORRECT TUBING ON THE ARCHITECT I2000SR ANALYZER PER THE MANDATORY TECHNICAL SERVICE BULLETIN. THERE WAS NO IMPACT TO PATIENT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5884246 ↗
• MalfunctionAug 17, 2016Fluid/Blood Leak; Fluid/Blood Leak

  FIELD SERVICE REPLACED THE INCORRECT TUBING ON THE ARCHITECT I2000SR ANALYZER PER THE MANDATORY TECHNICAL SERVICE BULLETIN. THERE WAS NO IMPACT TO PATIENT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5884168 ↗
• MalfunctionAug 17, 2016Fluid/Blood Leak; Fluid/Blood Leak

  FIELD SERVICE REPLACED THE INCORRECT TUBING ON THE ARCHITECT I2000SR ANALYZER PER THE MANDATORY TECHNICAL SERVICE BULLETIN. THERE WAS NO IMPACT TO PATIENT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5882593 ↗
• MalfunctionAug 1, 2016Fluid/Blood Leak; Fluid/Blood Leak

  FIELD SERVICE REPLACED THE INCORRECT TUBING ON THE ARCHITECT I2000SR ANALYZER PER THE MANDATORY TECHNICAL SERVICE BULLETIN. THERE WAS NO IMPACT TO PATIENT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5838137 ↗