ARCHITECT 3L79-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380740161491), received between Dec 17, 2020 and Jun 13, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULT GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. THE SAME SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL CALCIUM RESULT = 15.40 MG/DL; REPEAT RESULT = 9.29 MG/DL. PER THE CALCIUM REAGENT PACKAGE INSERT, THE REFERENCE RANGE FOR ADULT IS 8.4 TO 10.2 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201298 ↗
• MalfunctionMar 27, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6): INITIAL RESULT = 1.40 MMOL/L, REPEAT = 2.40 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707632 ↗
• MalfunctionMar 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR A 70-YEAR-OLD MALE IN-HOSPITAL PATIENT. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025 AT 10:22 AM: INITIAL CALCIUM RESULT = 1.47 MMOL/L (REFERENCE RANGE: 2.10-2.55 MMOL/L). THE INITIAL CALCIUM RESULT WAS REPORTED TO THE CLINICAL PHYSICIAN AND CONSIDERED THE RESULT OF 1.47 TO BE CRITICAL AND STARTED THE PATIENT ON INTRAVENOUS CALCIUM GLUCONATE. THE SAMPLE WAS RETESTED FOR CALCIUM ON THE SAME DAY, (B)(6) 2025 AT 11:39 AM AND AGAIN AT 13:21 PM GENERATING RESULTS OF 2.18 AND 2.20 MMOL/L WHICH WERE NORMAL. AFTER THE FIRST REPEATED RESULTS WERE REPORTED OUT, THE PHYSICIAN DISCONTINUED THE INTRAVENOUS CALCIUM GLUCONATE TREATMENT. THE PATIENT IS DOING WELL. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654751 ↗
• MalfunctionAug 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM (CA) RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 2.10 - 2.55 MMOL/L): (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT = 0.69 MMOL/L, SAME PATIENT NEW SAMPLE OBTAINED AT ANOTHER LAB AND RESULT ON UNKNOWN PLATFORM = 2.4 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084683 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE, CALCIUM 8.5-10.1): SID (B)(6) INITIAL CALCIUM RESULT= 17 MG/DL; REPEAT RESULT= 9.0 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341908 ↗
• MalfunctionApr 29, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: (B)(6)2024 SID (B)(6)= 1.21 / 2.37 MMOL/L (B)(6)2024 SID (B)(6)= 1.253 / 2.43 MMOL/L NORMAL RANGE: 2.15-2.55 MOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200141 ↗
• MalfunctionMar 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM GENERATED FROM AN ARCHITECT C8000 AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: CUSTOMER REFERENCE RANGE ¿ NORMAL IS UP TO 2.55 MMOL/L SAMPLE ID (B)(6) INITIAL RESULT WAS 3.547, REPEAT RESULTS WERE 2.526; 2.497; 2.494; 2.506; 2.504; 2.503; 2.492; 2.487; 2.495: 2.493: 2.499. PER THE CUSTOMER THE DISCREPANT RESULT(S) WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840832 ↗
• MalfunctionFeb 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED CALCIUM (CA) RESULT FOR A 41-YEAR-OLD MALE PATIENT WHEN RUNNING ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULTS (MMOL/L): CA = 1.3. REPEAT RESULTS (MMOL/L) CA = 2.45. THE CUSTOMER¿S REFERENCE RANGES WERE: CA: 2.11-2.52 MMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632135 ↗
• MalfunctionJun 20, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED FOR A PEDIATRIC PATIENT: SID (B)(6)INITIAL RESULT 2.20, REPEATED 0.53 AND 2.22 MMOL/L (REFERENCE RANGE PEDIATRIC 2.13-2.74 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162664 ↗
• MalfunctionMay 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS WERE QUESTIONED. THE CUSTOMER REPEATED AND THE RESULTS WERE HIGHER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED (B)(6) 2023 INITIAL RESULT = 0.529. REPEAT RESULTS = 2.76, 2.75, 2.72, 2.75, 2.75 REPEATED ON ANOTHER INSTRUMENT = 2.75. UOM = MMOL/L. REFERENCE RANGE = 2.15 MMOL/L TO 2.60 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876438 ↗
• MalfunctionJun 29, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. RESULTS PROVIDED: (CUSTOMER RANGE 8.4-10.2 MG/DL). SID (B)(6) INITIAL RESULT 5.9 MG/DL, REPEATED ON ANOTHER INSTRUMENT 9.4 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14850597 ↗
• MalfunctionJun 10, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CALCIUM RESULT OF 15.2 MG/DL WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 9.3 MG/DL. THE CUSTOMER'S NORMAL RANGE IS 8.4 - 10.0 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658824 ↗
• MalfunctionApr 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT CALCIUM RESULTS GENERATED ON AN ARCHITECT C4000 ANALYZER FOR TWO PATIENTS WHEN COMPARED TO RESULTS GENERATED ON ANOTHER ANALYZER. THE CUSTOMER PROVIDED REFERENCE RANGE IS 6.3-11.9 MG/DL. SID: (B)(4) INITIAL RESULT = 6.7 MG/DL, REPEAT =6.6 MG/DL, REPEAT ON ANOTHER ANALYZER = 6.0 MG/DL. SID (B)(4) INITIAL RESULT = 3.0 MG/DL, REPEAT RESULT = 3.1 MG/DL, REPEAT RESULT ON ANOTHER ANALYZER = 7.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250500 ↗
• MalfunctionApr 13, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT CALCIUM RESULT. THE CUSTOMER USES A NORMAL RANGE OF 8 TO 10 MG/DL. ON (B)(6) 2022 SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 3.4 MG/DL, WHICH WAS INCONSISTENT WITH THE PATIENT'S PREVIOUS RESULT OF (B)(6) MG/DL. THE SAMPLE WAS REPEAT TWICE AND GENERATED (B)(6) AND (B)(6) MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104255 ↗
• MalfunctionAug 31, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT CALCIUM RESULT. THE CUSTOMER'S NORMAL RANGE IS 8.4 TO 10.2 MG/DL. SAMPLE ID (B)(6) GENERATED 15.0, 11.8, 11.5 AND 9.5 MG/DL. A SECOND SAMPLE FROM THE PATIENT GENERATED 9.8 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393540 ↗
• MalfunctionMay 3, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 INSTRUMENT FOR ONE PATIENT. SID (B)(4) GENERATED CALCIUM RESULTS OF 44 / 90 / 92 MG/L; (CUSTOMER REFERENCE RANGE 84 MG/L TO 102 MG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11763561 ↗
• MalfunctionDec 17, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT CALCIUM RESULTS FOR ONE PATIENT. THE INITIAL INFORMATION FROM THE CUSTOMER PROVIDED: (B)(6) INITIAL = 3.00 MMOL/L, REPEAT = 2.21 MMOL/L (REFERENCE RANGE 2.10 TO 2.55 MMOL/L). ON (B)(6) 2020 THE CUSTOMER PROVIDED ADDITIONAL RESULTS FOR OF (B)(6), WHICH RANGED FROM 2.06 MMOL/L TO 4.40 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11030598 ↗