ARCHITECT 3L79-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380740005931), received between Feb 6, 2017 and Mar 14, 2022 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE (B)(6) FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) INITIAL=16.51 MG/DL /REPEATED AUTO DILUTION= < 10 MG/DL /REPEATED WITHOUT DILUTION=9.58 MG/DL. LABORATORY REFERENCE RANGE FOR CALCIUM=8.8 TO 10.0 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759119 ↗
• MalfunctionFeb 26, 2021Low Test Results; Low Test Results

  THE CUSTOMER GENERATED FALSELY DEPRESSED CALCIUM RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT C8000 PROCESSING MODULE. THE CUSTOMER'S NORMAL RANGE IS 2.1 - 2.6 MMOL/L. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) 2021 INITIAL RESULT 0.68 MMOL/L REPEATED 2.4 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388648 ↗
• MalfunctionDec 14, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT CALCIUM (CA) RESULTS FOR ONE PATIENT RUN ON TWO ARCHITECT ANALYZERS. THE CUSTOMER PROVIDED: SID (B)(6) INITIAL = 3.74 MMOL/L, REPEAT = 3.79 MMOL/L (NORMAL RANGE: (2.10 TO 2.55 MMOL/L). REPEATS ON ANOTHER ANALYZER FOR THIS SAME SAMPLE: 3.65, 4.66, 3.74, 3.79, 2.53, 2.88, AND 2.82 MMOL/L. THE OTHER VALUES PROVIDED FROM THE CUSTOMER FOR ALL RESULTS ASSOCIATED WITH THIS TEST WERE REVIEWED AND NONE MET REPORTABILITY CRITERIA THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11002251 ↗
• MalfunctionApr 22, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT FOR ONE PATIENT ON THE ARCHITECT ANALYZER, THAT UPON REPEAT WAS WITHIN THE NORMAL RANGE. RESULTS PROVIDED FOR (B)(6): INITIAL= 4.329 MMOL/L, REPEAT= 2.40 MMOL /L (NORMAL RANGE = 2.10 TO 2.55 MMOL/L); RETESTED SECOND TIME = 2.19MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9986024 ↗
• MalfunctionApr 13, 2020Low Test Results; Low Test Results

  THE ACCOUNT GENERATED FALSE DEPRESSED ARCHITECT CALCIUM RESULTS ON MULTIPLE SAMPLES THAT REPEATED HIGHER. ID (B)(6) TESTED 5.88 BUT REPEATED 8.77 MG/DL ON (B)(6) 2020. ID (B)(6)TESTED 6.02 BUT REPEATED 9.26, 9.33 MG/DL ON (B)(6) 2020. ID (B)(6) TESTED 5.93 BUT REPEATED 8.64 MG/DL ON (B)(6) 2020. ID (B)(6) TESTED 3.90 BUT REPEATED 9.0 MG/DL ON (B)(6) 2020. ID (B)(6) TESTED 4.75 BUT REPEATED 8.98 MG/DL ON (B)(6) 2020. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9955523 ↗
• MalfunctionMar 20, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ARCHITECT C4000 ON ONE PATIENT. RESULTS PROVIDED: (B)(6) = 15.1 / 10.1 MG/DL (NORMAL RANGE: 8.4-10.4 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9859515 ↗
• MalfunctionFeb 14, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000 ON ONE PATIENT. RESULTS PROVIDED: 02DEC2019 = 1.09 / 2.14 / 2.6 MMOL/L, CUSTOMERS NORMAL RANGE: NEWBORN (MMOL / L), PREMATURE 1.55 TO 2.75, 0 TO 10 DAYS 1.90 TO 2.60, 10 DAYS TO 24 MONTHS 2.25 TO 2.75. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712112 ↗
• InjuryJan 16, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT CALCIUM OF 3.03 MMOL/L WITH SID (B)(6) ON (B)(6) 2019 MORNING ON A (B)(6)-YEAR OLD CAUCASIAN FEMALE LUNG CANCER PROGRESSIVE MALIGNANCY PATIENT WHO WAS TREATED WITH APD INFUSION (BIPHOSPHONATES INFUSION - PAMIDRONATES) DUE TO THE ELEVATED CALCIUM RESULT. THE SAMPLE REPEATED ARCHITECT CALCIUM OF 2.46 MMOL/L ON (B)(6) 2019 AT 15:35 WHICH WAS THE CORRECT RESULT REPORTED TO THE PHYSICIAN BUT THE APD INFUSION HAD FINISHED. ADDITIONAL TESTING WAS CALCIUM OF 2.33 MMOL/L ON (B)(6) 2019 AND 2.16 MMOL/L ON (B)(6) 2019. PRIOR TO APD INFUSION, THE PATIENT WAS VERY SICK. DAYS AFTER THE APD INFUSION, THE PATIENT WENT TO THE HOSPITAL WITH FEVER, DID NOT FEEL WELL AND BLAMED THE APD INFUSION. THE PATIENT RECEIVED AMOXI IV AS TREATMENT FOR THE FEVER. THE PATIENTS PLANNED CHEMOTHERAPY WAS POSTPONED 7 DAYS DUE TO THE ELEVATED CALCIUM RESULT. HISTORICAL PATIENT CALCIUM WAS 2.32 MMOL/L ((B)(6) 2002), 2.43 MMOL/L ((B)(6) 2002), 2.42 MMOL/L ((B)(6) 2002), 2.37 MMOL/L ((B)(6) 2002), 2.33 MMOL/L ((B)(6) 2003), 2.24 MMOL/L ((B)(6) 2018), 2.37 MMOL/L ((B)(6) 2019), 2.41 MMOL/L ((B)(6) 2019), 2.40 MMOL/L ((B)(6) 2019), 2.43 MMOL/L ((B)(6) 2019), 2.45 MMOL/L ((B)(6

  Patient problems: Test Result

  MAUDE report 9598252 ↗
• MalfunctionDec 4, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = 17.2 / 9.4 / 9.6 MG/DL. NORMAL RANGE: (8.4-10.2 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9410086 ↗
• MalfunctionOct 7, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT ANALYZER FOR 1 PATIENT. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = MG/DL, REFERENCE RANGE = 8.4 TO 10.2 MG/DL): ON (B)(6) 2019 SID (B)(6) INITIAL RESULT = 2.2, REPEAT = 9.5. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162544 ↗
• MalfunctionSep 20, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/L): INITIAL 19.897, REPEAT 21.120. THE SAMPLE WAS REPEATED AND CONFIRMED AT 94 MG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9099551 ↗
• MalfunctionSep 15, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE DECREASED CALCIUM RESULT OF 0.35 MMOL/L, WHEN PROCESSING ON THE ARCHITECT C8000. PREVIOUS RESULTS FOR THIS PATIENT HAVE ALWAYS RANGED FROM 1.94 TO 2.31 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9062819 ↗
• MalfunctionSep 4, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT ANALYZER FOR 1 PATIENT. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = MG/DL, REFERENCE RANGE = 8.4 TO 10.2 MG/DL): ON (B)(6) 2019 SID (B)(6) INITIAL RESULT = 2.2, REPEAT = 9.5. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959348 ↗
• MalfunctionMar 25, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT CALCIUM RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT WAS 19.1 MG/DL AND RETEST 9.3 MG/DL, FOR SID (B)(6). THE CUSTOMER USES A NORMAL RANGE OF 8.7-10.3 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449134 ↗
• MalfunctionFeb 12, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED CALCIUM (CA) RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL = 2.4MG/DL / REPEATED ON DIFFERENT ANALYZER = 8.7MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332065 ↗
• MalfunctionJan 10, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE DECREASED ARCHITECT CALCIUM RESULT OF LESS THAN 20 MG/L. REPEAT RESULTS WERE 94.72 AND 93.79 MG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235561 ↗
• MalfunctionDec 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 1.39, REPEAT 2.27 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188279 ↗
• MalfunctionOct 18, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED A FALSELY ELEVATED PATIENT RESULT (SAMPLE ID (B)(6)) WHEN USING ARCHITECT CALCIUM ASSAY. INITIAL RESULT: 4.268 MMOL/L. SAMPLE RERUN RESULT: 2.415 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT REPORTED. PATIENT AGE, GENDER, RACE AND ETHNICITY WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7980680 ↗
• MalfunctionOct 17, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED MULTIPLE FALSE ELEVATED ARCHITECT CALCIUM RESULTS ON THE ARCHITECT C16000 ANALYZER. SAMPLE ID 9175964JP GENERATED AN INITIAL RESULT OF 5.13 MMOL/L AND RETEST OF 2.20 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975515 ↗
• MalfunctionJul 23, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS ON ONE PATIENT. THE INITIAL SAMPLE WAS DRAWN AT THE PHYSICIANS SITE: SAMPLE FROM (B)(6) 2018 (B)(6) ON (B)(6) 2018 CA = 4.26 / 4.16 / 4.05 / 3.9 MMOL/L(2.23-2.5 MMOL/L). THE RESULTS WERE REPORTED AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHERE A NEW SAMPLE WAS DRAWN: (B)(6) CA = 2.37. THE ORIGINAL (B)(6) WAS REPEATED ON (B)(6) 2018 CA = 2.4; ON (B)(6) 2018 DIFFERENT TUBE SAME DRAW (B)(6) CA RUN 21X AND THE RESULTS RANGED FROM 1.91 TO 2.06. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710691 ↗
• MalfunctionJul 1, 2018High 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 15.8, REPEATS 9.4, 9.4 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654097 ↗
• MalfunctionJun 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CALCIUM (CA) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL DRAW = 1.39MMOL/L / REPEAT = 1.38MMOL/L / NEW DRAW SAME DAY = 2.25MMOL/L / RETEST OF ORIGINAL SAMPLE = 2.32MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7573682 ↗
• MalfunctionMay 11, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT DECREASED ARCHITECT CALCIUM RESULTS WERE GENERATED ON MULTIPLE PATIENTS. THE CUSTOMER WAS USING A NORMAL RANGE OF 8.4-10.5 MG/DL. (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506604 ↗
• MalfunctionNov 8, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTS THE FOLLOWING PATIENT ARCHITECT CLIN CHEM CALCIUM ASSAY RESULTS GENERATED ON AN ARCHITECT C16000 ANALYZER: (B)(6). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7008823 ↗
• MalfunctionSep 27, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED INTERMITTENT DISCREPANT CALCIUM RESULTS FOR PATIENT SAMPLES TESTED ON THE ARCHITECT C8000. AN INITIAL RESULT OF 14.7 MG/DL (CRITICAL HIGH) RETESTED AT 9.7 MG/DL (NORMAL). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6897313 ↗