ARCHITECT 7D70-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380740012939), received between Aug 1, 2017 and Dec 22, 2020 — classified as 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 2, 2019Terminated

   Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.

   Z-0971-2019 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED MAGNESIUM RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMERS REFERENCE RANGE IS 0.75-1.02 MMOL/L): SAMPLE (B)(6) INITIAL RESULT WAS 0.24, REPEATED, UNDER SAMPLE ID (B)(6), WAS 0.77 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11058369 ↗
• MalfunctionOct 21, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM (MG) RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER. RESULTS PROVIDED: SID (B)(6) ON (B)(6) 2019 = 2.3 / 0.9 MEQ/L (NORMAL RANGE: 1.3-2.1 MEQ/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9214936 ↗
• MalfunctionJul 29, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM (MG) RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER. RESULTS PROVIDED: SID (B)(6), (B)(6) 2019 = 2.3 / 0.9 MEQ/L (NORMAL RANGE: 1.3-2.1 MEQ/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837657 ↗
• MalfunctionMay 21, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE INITIAL RESULT WAS GREATER THAN 8.0 MG/DL, REPEATED AT 2.0 AND 2.1 MG/DL NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627875 ↗
• MalfunctionDec 22, 2018High Test Results; High Test Results

  THE ACCOUNT GENERATED A FALSE ELEVATED ARCHITECT MAGNESIUM (7.33 MG/DL) THAT REPEATED ON ANOTHER ANALYZER (2.34, 2.39 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 8193074 ↗
• MalfunctionNov 12, 2018High Test Results; High Test Results

  THE CUSTOMER GENERATED A FALSELY ELEVATED MAGNESIUM RESULT WHILE USING THE CLINICAL CHEMISTRY MAGNESIUM ASSAY ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULT DATA: SID (B)(6): INITIAL 8.6 MG/DL, RETEST 1.7 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059823 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A MALE PATIENT: (B)(6) INITIAL 6.3, REPEAT 1.8 AND 1.9 MG/DL. THE SAMPLE WAS CONFIRMED AT 1.7 ON ANOTHER METHOD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7899908 ↗
• MalfunctionAug 30, 2018High Test Results; High Test Results

  THE ACCOUNT OBSERVED FALSELY ELEVATED ARCHITECT MAGNESIUM ON 2 PATIENT SAMPLES THAT REPEATED LOWER. (B)(6) WAS 3.03 BUT REPEATED 1.3 MG/DL. (B)(6) WAS 2.79 BUT REPEATED 1.3 MG/DL. THE ACCOUNT USES A NORMAL RANGE OF 1.6 TO 2.6 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 7836030 ↗
• MalfunctionAug 23, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): SID W10289 INITIAL 3.3, REPEATS 3.2, 1.2, 1.2; SID W11215 INITIAL 2.9, REPEATS 2.9, 1.3, 1.3; SID 5085854 INITIAL 3.3, REPEATS 1.2, 1.0, 1.9; SID 257642 INITIAL 2.9, REPEAT 1.3. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810395 ↗
• MalfunctionJun 28, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED MAGNESIUM IMPRECISION ON THE ARCHITECT C16000 SYSTEM. PATIENT 1: INITIAL RESULT OF <0.7 MG/DL RETESTED AT 2.7 MG/DL. PATIENT 2: INITIAL RESULT OF 0.7 MG/DL RETESTED AT 2.3 MG/DL ON A DIFFERENT ANALYZER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7647917 ↗
• MalfunctionJun 28, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ARCHITECT MAGNESIUM RESULT ON THE ARCHITECT C16000 ANALYZER. SAMPLE 1 GENERATED AN INITIAL MAGNESIUM RESULT OF 1.0 MG/DL AND RETEST ON A SECOND ANALYZER GENERATED 2.0 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647853 ↗
• MalfunctionJun 27, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT FOR AN (B)(6) MALE. SAMPLE ID (B)(6): INITIAL 8.9 MG/DL, RETEST 2.9 MG/DL, RETEST ALTERNATE ARCHITECT 2.0 MG/DL. A NEW SAMPLE WAS COLLECTED (SAMPLE ID (B)(6)) GENERATED 2.3 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642498 ↗
• MalfunctionJun 26, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): PATIENT 1 INITIAL 7.5, REPEAT 2.1; PATIENT 2 INITIAL 6.0, REPEAT 2.3. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639579 ↗
• MalfunctionNov 16, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED AN INITIAL FALSE ELEVATED ARCHITECT MAGNESIUM RESULT. SAMPLE (B)(6)GENERATED AN INITIAL RESULT OF 6.97 MG/DL AND REPEAT GENERATED A RESULT OF 2.1 MG/DL. THE CUSTOMER USES A NORMAL RANGE OF 1.6 TO 2.6 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037177 ↗
• MalfunctionSep 15, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT MAGNESIUM RESULTS FOR TWO PATIENTS. THE CUSTOMER USES A NORMAL RANGE OF 1.6 TO 2.6 MG/DL. THE FOLLOWING DISCREPANT RESULTS WERE PROVIDED: PATIENT 3: INITIAL 7.3 AND REPEAT 1.5 MG/DL. PATIENT 5: INITIAL 6.9 AND REPEAT 1.7 MG/DL . NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6870692 ↗
• MalfunctionAug 1, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED MAGNESIUM RESULTS WHILE USING THE CLINICAL CHEMISTRY MAGNESIUM REAGENTS. THE CUSTOMER USES REFERENCE RANGE LESS THAN 2 MG/DL. THE CUSTOMER STATED THAT THE INITIAL RESULTS WERE GREATER THAN 8 AND THE REPEAT RESULTS WERE LESS THAN 2, HOWEVER SPECIFIC RESULTS PER PATIENT WERE NOT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758705 ↗