ARCHITECT 3L79-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380740005948), received between Feb 23, 2017 and Aug 4, 2020 — classified as 24 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) INITIAL CALCIUM RESULT=21.3 MG/DL. REDRAW AND REPEATED RESULT=8.8 MG/DL. REPEATED ON ANOTHER ARCHITECT (B)(4) =8.6 MG/DL. (CALCIUM CRITICAL=LESS THAN 6 MG/DL OR GREATER THAN 13 MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10364414 ↗
• MalfunctionJul 28, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) CALCIUM RESULTS=3.09 MMOL/L AND 4.10 MMOL/L/ RESULTS FROM ANOTHER ARCHITECT C1600561=2.29 MMOL/L AND 2.14 MMOL/L /REPEATED ON ANOTHER ARCHITECT C1600377=2.20 MMOL/L AND 2.18 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10333861 ↗
• MalfunctionJul 10, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE: 8.4 TO 10.2 MG/DL) : (B)(6) 2020 INITIAL RESULT = 16.1 MG/DL, REPEAT = 11.1 MG/DL, NEW DRAW SPECIMEN: INITIAL RESULT = 9.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10260450 ↗
• MalfunctionJun 10, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL CALCIUM RESULT = 0.95 MMOL/L, REPEATS ON ANOTHER ARCHITECT = 2.21MMOL/L AND 2.22MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140626 ↗
• MalfunctionOct 21, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED CALCIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: SID (B)(6) ON (B)(6) 2019 = 2.3 MG/DL / REPEATED SAME SAMPLE: SID (B)(6) ON (B)(6) 2019 = 9.6 MG/DL. (NORMAL RANGE: 8.5-10.5 MG/DL) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9215203 ↗
• MalfunctionSep 23, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 3.87, REPEAT 3.03, 2.51 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9106750 ↗
• MalfunctionAug 21, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CALCIUM RESULTS FOR A (B)(6) YEAR OLD FEMALE PATIENT. THE SAMPLE GENERATED ARCHITECT RESULTS OF 3.09, 3.96 AND 3.17 MMOL/L. THE SAMPLE WAS RETESTED ON THE MINDRAY BS-2000M AND GENERATED NORMAL RESULTS OF 2.71 AND 2.74 MMOL/L. THE SAMPLE WAS RECENTRIFUGED AND RETESTED ON THE ARCHITECT GENERATING 2.53 AND 2.60 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8918398 ↗
• MalfunctionJul 29, 2019Low 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) 2019= 2.3 MG/DL / REPEATED SAME SAMPLE: (B)(6) ON (B)(6) 2019 = 9.6 MG/DL. (NORMAL RANGE: 8.5-10.5 MG/DL) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837660 ↗
• MalfunctionMay 14, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CALCIUM RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT WAS 4.2023 MMOL/L AND RETEST WAS 2.2475 MMOL/L. THE CUSTOMER USES A REFERENCE RANGE OF 2.10-2.55 MMOL/L. AN ARCHIVED SPECIMEN (WITH AN INITIAL RESULT OF 3.2538 MMOL/L) WAS RETESTED WITH CONSISTENT RESULTS AS THE RETEST RESULT WAS 3.2916 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8608163 ↗
• MalfunctionFeb 15, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CALCIUM RESULT WHEN PROCESSING ON THE ARCHITECT C8000. THE INITIAL RESULT WAS 140 MG/L (14MG/DL). RETEST YIELDED A RESULT IN NORMAL RANGE (NO SPECIFIC VALUE PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342753 ↗
• MalfunctionOct 25, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CALCIUM RESULT. SAMPLE ID IA0900329SS GENERATED AN INITIAL RESULT OF 10.92 MEQ/L. THE SAMPLE WAS RETESTED MULTIPLE TIMES RANGING FROM 3.51 MEQ/L TO 4.98 MEQ/L. THE CUSTOMER USES A NORMAL RANGE OF 4.09 TO 5.58 MEQ/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8006894 ↗
• MalfunctionAug 6, 2018High Readings; High Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS ON TWO PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: PT#1 ON 13JUL2018 CA =14.5 / REPEATED X2 = 10.2 / 10.0MG/DL (NORMAL RANGE = 7.9-10.7MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754501 ↗
• MalfunctionJul 30, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT CALCIUM OF 3.99 MMOL/L WHEN PROCESSING ON THE ARCHITECT C8000. THE SAMPLE REPEATED ARCHITECT CALCIUM OF 2.34 MMOL/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732985 ↗
• MalfunctionJun 1, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CALCIUM RESULT ON THE ARCHITECT C16000 ANALYZER. THE SAMPLE GENERATED AN INITIAL RESULT OF 4.93 MMOL/L AND RETEST GENERATED 2.23 MMOL/L. THE CUSTOMER USES A NORMAL RANGE OF 2.20 TO 2.60 MMOL/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7562296 ↗
• MalfunctionMar 14, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT CALCIUM RESULTS ON PATIENT SAMPLES THAT REPEATED IN THE NORMAL RANGE. EXAMPLES WERE PROVIDED OF 23 PATIENTS SAMPLES WITH ELEVATED ARCHITECT CALCIUM RANGING 15.8 TO 14.8 MG/DL THAT REPEATED IN THE NORMAL RANGE OF 8.4 TO 10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339675 ↗
• MalfunctionSep 7, 2017High Test Results; High Test Results

  THE CUSTOMER INDICATED THAT AN ELEVATED CALCIUM RESULT OF 5.09 MMOL/L WAS GENERATED ON THE ARCHITECT C16000 ANALYZER. THE SAMPLE WAS REPEATED AND A RESULT OF 2.22 MMOL/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849951 ↗
• MalfunctionAug 28, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 4.13, REPEAT 3.86, 2.41, 2.42 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825559 ↗
• MalfunctionAug 28, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 INITIAL 3.3, REPEAT 9.4 MG/DL; PATIENT 2 INITIAL 7.8, REPEAT 9.1 MG/DL ; PATIENT 3 INITIAL 5.6, REPEAT 9.1MG/DL; THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825174 ↗
• MalfunctionJun 21, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CLINICAL CHEMISTRY CALCIUM RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (CUSTOMER PROVIDED RANGE 8.3-10.0): SID (B)(6): INITIAL 0.8 MMOL/L, RETESTED ON A DIFFERENT ANALYZER: 2.25 MMOL/L. THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657972 ↗
• MalfunctionMay 17, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CLINICAL CHEMISTRY CALCIUM RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (CUSTOMER PROVIDED RANGE 8.3-10.0): PT IDENTIFIER: (B)(6), INITIAL 0.8 MMOL/L, RETESTED ON A DIFFERENT ANALYZER: 2.25 MMOL/L. THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572246 ↗
• MalfunctionMay 12, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTS THAT FROM (B)(6) 2016, ONE PATIENT GENERATED THE FOLLOWING CLIN CHEM (B)(6). THE PATIENT IS TAKING A DAILY CALCIUM CARBONATE SUPPLEMENT AND ONE DOSE OF VITAMIN D.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6565321 ↗
• MalfunctionApr 19, 2017Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY DECREASED CALCIUM RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2016 AT 8:14 AM INITIAL CALCIUM = 1.29 / REPEATED = 1.90 / 1.87 / REPEATED ON ANOTHER ARCH = 1.89MMOL/L. 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 6505396 ↗
• MalfunctionMar 6, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY LOW CALCIUM RESULT GENERATED USING CLINICAL CHEMISTRY CALCIUM REAGENTS. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES NORMAL RANGE 8.7 TO 10.4 MG/DL. INITIAL 5.1, REPEAT 9.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382193 ↗
• MalfunctionFeb 23, 2017Low Test Results; Low Test Results

  THE CUSTOMER INDICATED THAT DISCREPANT CALCIUM RESULTS WERE GENERATED ON THE ARCHITECT C16000 ANALYZER. A PATIENT SAMPLE GENERATED AN INITIAL RESULT OF 1.42 MMOL/L. THE SAMPLE WAS REPEATED AND A RESULT OF 2.43 MMOL/L WAS GENERATED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6354399 ↗