ARCHITECT 3L79-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740161507), received between Dec 22, 2020 and Dec 4, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR A 57-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED PATIENT NORMAL RANGE: 8.4-10.5 MG/DL, PATIENT CRITICAL LOW= <6.0 MG/DL, PATIENT CRITICAL HIGH= >13.0 MG/DL) ON (B)(6) 2025 SID (B)(6) INITIAL RESULT = 5.9 MG/DL, THE EMERGENCY ROOM DREW ANOTHER SAMPLE SHORTLY AFTER AS A POINT OF CARE AND THEY GOT A NORMAL RESULT. (NO SPECIFIC RESULT PROVIDED) ON (B)(6) 2025 REPEAT RESULT OF SAME SAMPLE ON ANOTHER ARCHITECT (B)(6) = 9.6 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716474 ↗
• MalfunctionJul 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT 3.53 MMOL/L, REPEATED 2.21 MMOL/L, A NEW SAMPLE WAS OBTAINED THE NEXT DAY AND THE RESULT WAS 2.19 MML/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675417 ↗
• MalfunctionApr 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM GENERATED FROM ARCHITECT C16000 ANALYZER. THE CUSTOMER COMPARED RESULTS WITH OTHER ANALYZERS, INCLUDING THE ALINITY C PLATFORM AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE FOR ADJUSTED CALCIUM IS 2.2-2.6MMOL/L. CUSTOMER REFERENCE RANGE FOR CALCIUM IS 1.75-3MMOL/L. SAMPLE ID: (B)(6): RESULT ON ARCHITECT WAS 4.28 MMOL/L. ADDITIONAL RESULTS ON ARCHITECT WERE 2.64, 2.07, 2.07, 2.10, 2.14, 2.09, 2.05, 2.03, 2.04, 2.07, 2.05 MMOL/L. RESULT ON ALINITY WAS 3.04 MMOL/L. 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 21906143 ↗
• MalfunctionMar 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY LOW CALCIUM RESULTS GENERATED FROM ARCHITECT C16000. THE INITIAL TEST RESULTS OF TWO SAMPLES WERE LESS THAN THE CRITICAL VALUE OF 1.75MMOL/L, AND THE RETEST RESULTS WERE WITHIN THE NORMAL RANGE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE IS 2.10-2.80 MMOL/L. SAMPLE 1 WAS INITIALLY MEASURED AT 1.48 MMOL/L, AND THE RETEST WAS 2.38MMOL/L. SAMPLE 2 WAS INITIALLY MEASURED AT 1.38MMOL/L, AND THE RETEST WAS 2.33MMOL/L. 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 21654701 ↗
• MalfunctionDec 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000. ANALYZER ON A PATIENT. RESULTS PROVIDED: PT 2: 3.06 / 3.5 / 2.53 / 2.54 / 2.60 MMOL/L (REFERENCE RANGE: 2.1-2.8 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877230 ↗
• MalfunctionJan 26, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER FOR ONE PATIENT. DUE TO THE FALSELY DECREASED CALCIUM, THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND WAS RETESTED WITH HIGHER CALCIUM RESULT. THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE ON THE TWO ANALYZERS AND THE RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 2.5 MG/DL; REPEAT RESULTS = 10.0 TO 10.2 MG/DL. RESULT FROM EMERGENCY ROOM SAMPLE = 10.0 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245905 ↗
• MalfunctionJun 10, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CALCIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID D22275390Q=1.46 MMOL/L /REPEATED=2.29 MMOL/L /REPEATED ON ARCHITECT C1601335=2.32 MMOL/L LABORATORY REFERENCE RANGE FOR CALCIUM=2.20 TO 2.26 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655467 ↗
• MalfunctionMay 11, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON THE ARCHITECT C16000 PROCESSING MODULE. TWO EXAMPLES WERE PROVIDED. SID (B)(4) 15.6 MG/DL (C16000), 9.63 MG/DL (C8000), SID (B)(4) 16.3 MG/DL (C16000), 9.47 MG/DL (C8000), NORMAL RANGE: 8.4 TO 10.2 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14361121 ↗
• MalfunctionDec 17, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED FALSELY DEPRESSED AND INCONSISTENT ARCHITECT CALCIUM RESULTS. THE CUSTOMER'S REFERENCE RANGE IS 2.2 TO 2.6 MMOL/L. THE FOLLOWING INITIAL AND REPEAT RESULTS WERE PROVIDED: (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025235 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER FOR ONE SAMPLE THAT THE PHYSICIAN QUESTIONED. THE FOLLOWING DATA WAS PROVIDED (THE CUSTOMER¿S REFERENCE RANGE IS 8.5 TO 10.5 MG/DL): (B)(6) 2021 SID (B)(6) INITIAL RESULT = (B)(6) MG/DL, REPEAT = (B)(6) MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861602 ↗
• MalfunctionSep 14, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON ALL THREE ARCHITECT C8000 PROCESSING MODULES WHEN CHANGING TO A NEW LOT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER NORMAL RANGE 2.1 TO 2.6 MMOL/L): SID (B)(6), ARCHITECT RESULTS >6.00 / 3.48 / 5.49 MMOL/L, REPEATED ON THE ROCHE PLATFORM 2.48 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469034 ↗
• MalfunctionJun 17, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT FOR A PATIENT WHEN USING THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2021: SID (B)(6) = INITIAL RESULT = 0.71 MMOL/L, REPEAT = 2.40 MMOL/L (C4 ANALYZER), REPEAT ON ANOTHER ANALYZER IN THE LAB (C3 ANALYZER) = 2.34 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018058 ↗
• MalfunctionJun 3, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS WERE GENERATED FOR A PATIENT ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER STATED ON (B)(6) 2021 SID (B)(6) GENERATED AN INITIAL RESULT OF 19.10 MG/DL, WITH A REPEAT RESULT OF 9.33 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930396 ↗
• MalfunctionJan 28, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED CALCIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) = 2.9 MG/DL, SAMPLE REDRAWN = 9.3 MG/DL. NORMAL RANGE: 8.5-10.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11247421 ↗
• MalfunctionDec 22, 2020High Test Results; High Test Results

  THE ACCOUNT OBSERVED FALSE ELEVATED AND IMPRECISE ARCHITECT CALCIUM RESULTS WHEN PROCESSING ON MULTIPLE ARCHITECT C16000 ANALYZERS, SERIALS (B)(4).. SID (B)(6). CALCIUM RESULTS RANGED 3.62 TO 3.07 MMOL/L. A SECONDARY TUBE GENERATED CALCIUM RESULTS RANGED 5.22 TO 3.25 MMOL/L. TROUBLESHOOTING INCLUDED REPLACING THE SAMPLE PROBE, REPEATING ON ADDITIONAL ANALYZERS WITH CONTINUED IMPRECISE RESULTS RANGING 2.76 TO 2.29 MMOL/L. AFTER TRANSFERRING THE SPECIMEN TO A SAMPLE CUP FOR PROCESSING RESULTS RANGING 2.16 TO 2.12 MMOL/L. SID (B)(6) GENERATED RESULTS OF 5.47, 3.22, 3.24, 2.87, 3.27, 1.85, 1.83 MMOL/L ON SERIAL (B)(4). SID (B)(6) GENERATED RESULTS OF 2.83 TO 4.13 MMOL/L. SID (B)(6) GENERATED RESULTS OF 2.85 TO 4.08 MMOL/L. SID (B)(6) GENERATED RESULTS OF 2.44 TO 5.20 MMOL/L. SID (B)(6) GENERATED RESULTS OF 2.96 TO 4.22 MMOL/L. SID (B)(6) GENERATED RESULTS OF 3.20 TO 3.71 MMOL/L ON (B)(6) 2020 ON SERIAL (B)(4), BUT REPEATED ON ALL 3 ARCHITECT ANALYZERS RANGING FROM 1.98 TO 2.63 MMOL/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11055969 ↗