ARCHITECT 3L80-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740005962), received between Aug 29, 2016 and Mar 24, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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.

• MalfunctionMar 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CO2 RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THEY TESTED WITHIN THE CRITICAL RANGE ON THE C4000 AND WHEN REPEATED ON THE C8000 (SN (B)(6) ARE WITHIN NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL 15.8 ON C4100. REPEAT 18 ON C8200. ISTAT 22 (CUSTOMER IS UNSURE OF THE EXACT VALUE BUT MD CLAIMS IT WAS WITHIN NORMAL RANGE) NORMAL RANGE 22 ¿ 29, UOM MMOL/L). THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON INITIAL FALSE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610214 ↗
• MalfunctionFeb 14, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED FALSELY ELEVATED ARCHITECT CO2 RESULTS FOR PATIENT SAMPLES AND CONTROLS. THE CUSTOMER INDICATED AFTER USING A KIT FOR TWO HOURS THE RESULTS SHIFT HIGH AND WHEN RETESTED ON AN ALTERNATE ANALYZER GENERATE LOWER RESULTS. THE CUSTOMER INDICATED 8 SAMPLES GENERATED INITIAL RESULTS AROUND 40 MMOL/L AND WHEN RETESTED ON AN ALTERNATE METHOD GENERATED RESULTS AROUND 20 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714447 ↗
• MalfunctionNov 19, 2018Low Test Results; Low Test Results

  THE ACCOUNT STATED THE ARCHITECT CARBON DIOXIDE (CO2) IS GENERATING PATIENT VALUES 4 TO 5 UNITS LOWER THAN EXPECTED. AN EXAMPLE WAS PROVIDED OF ARCHITECT CO2 OF 16 MMOL/L BUT LAST MONTH THE PATIENT WAS 24 MMOL/L. THE NORMAL CUSTOMER RANGE IS 22 TO 31 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087577 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CARBON DIOXIDE RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(4) INITIAL CO2 32, REPEAT 29 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919998 ↗
• MalfunctionSep 20, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED A FALSELY ELEVATED PATIENT RESULT FOR ARCHITECT CARBON DIOXIDE AND WHEN REPEATED WAS NORMAL. THE CUSTOMER PROVIDED (B)(6): INITIAL RESULT 33 MEQ/L AND SAME DAY REPEAT RESULT 28 MEQ/L (ACCOUNT NORMAL RANGE 23-31MEQ/L). NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE ACCOUNT DOES NOT KNOW SPECIFIC PATIENT INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895185 ↗
• MalfunctionJul 19, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CARBON DIOXIDE RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MMOL/L): 1818400847B INITIAL CO2 32, REPEAT 29 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704884 ↗
• MalfunctionMay 26, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CO2 RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 13.4, REPEAT 18.4, 22 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NEAT SAMPLE - 13.4. WHEN THE SAMPLE WAS DILUTED ONE PART SAMPLE TO ONE PART SALINE, THE FINAL (CALCULATED) RESULT WAS 18.4. WHEN THE SAMPLE WAS DILUTED ONE PART SAMPLE TO TWO PARTS SALINE, THE FINAL (CALCULATED) RESULT WAS 22. THE PATIENTS ACIDOSIS IS NORMAL ON BLOOD GAS ANALYSIS WITH A NORMAL BLOOD PH AND BICARBONATE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6594125 ↗
• MalfunctionMay 5, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED CO2 RESULTS OF 11, 8, 13, <5 MMOL/L WERE GENERATED USING SEVERAL ARCHITECT ANALYZERS WITH A PATIENT WHO TESTED SIEMENS RAPID POINT 500 BLOOD GAS ANALYZER OF 24.2 MMOL/L. THE ACCOUNT USES A NORMAL CO2 REFERENCE RANGE OF 22 TO 30 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6548576 ↗
• MalfunctionApr 10, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CARBON DIOXIDE RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 8 INITIAL 11, REPEATS 23 MEQ/L THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477019 ↗
• InjuryMar 30, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCREPANT CO2 RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL CO2 RUN GENERATED EC 1051 UNABLE TO CALCULATE RESULT, ABSORBANCE EXCEEDED OPTICAL LIMITS. SPECIMEN HAD 4+ LIPEMIA. LIKELY CAUSE OF 1051 ERROR. SYSTEM WAS CONFIGURED TO PERFORM THE 1:2 AUTO-DILUTION ON ABS ERRORS. AS SUCH, INSTRUMENT AUTOMATICALLY PERFORMED THE 1:2 DILUTION WHICH YEILDED A <10 RESULT TECH THEN PERFORMED A MANUAL 1:5 DILUTION WHICH YEILDED A <25 RESULT. TECH MANUALLY REPORTED <25 MMOL/L RESULT TO EMERGENCY DEPT ON FEB 25, 2017. THE TEST WAS REPEATED AS <5 WHEN THE PATIENT RETURNED TO THE EMERGENCY ROOM 3 DAYS LATER IN A COMA. (NOTE: THE PACKAGE INSERT STATES THE LOWER LIMIT OF LINEARITY IS 5 MMOL/L.) RETROSPECTIVE REVIEW FROM THE EMERGENCY DEPARTMENT STAFF IS THEY BELIEVE THEY WOULD HAVE ADMITTED THE PATIENT TO THE HOSPITAL IF THEY HAD REALIZED THE CO2 WAS <10, AS <10 IS CONSIDERED A CRITICAL VALUE. SINCE THE <25 WAS REPORTED AND NORMAL RANGE IS 22-29, THE RESULT WAS OVERLOOKED AS IT WAS NOT FLAGGED IN THEIR LIS OR CALLED CRITICAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017, HOWEVER NO FURTHER PATIENT DETAILS WERE PROVIDED.

  Patient problems: Coma

  MAUDE report 6447573 ↗
• MalfunctionJan 31, 2017Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER IS GENERATING FALSELY DECREASED CO2 RESULTS COMPARED TO THEIR SISTER FACILITY. THE RESULT EXAMPLE PROVIDED: SAMPLE FROM (B)(6) 2016 CO2 =17 (RANGE 20-29)/ REDRAWN ON (B)(6) 2016 = 15 / PHYSICIAN QUESTIONED THE RESULT SO PATIENT WAS REDRAWN AT SISTER SITE AND THE (B)(4) = 24 (RANGE 21-31). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6289436 ↗
• MalfunctionAug 29, 2016High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CO2 RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 13.4, REPEAT 18.4, 22 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NEAT SAMPLE - 13.4: WHEN THE SAMPLE WAS DILUTED, ONE PART SAMPLE TO ONE PART SALINE, THE FINAL (CALCULATED) RESULT WAS 18.4. WHEN THE SAMPLE WAS DILUTED, ONE PART SAMPLE TO TWO PARTS SALINE, THE FINAL (CALCULATED) RESULT WAS 22. THE PATIENTS ACIDOSIS IS NORMAL ON BLOOD GAS ANALYSIS WITH A NORMAL BLOOD PH AND BICARBONATE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5911247 ↗