ARCHITECT 7D70-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380740012922), received between May 3, 2017 and Oct 25, 2021 — classified as 37 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON AN ARCHITECT C4000 ANALYZER FOR FOUR PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT = 2.59 MMOL/L; REPEAT RESULT = 0.81 MMOL/L. SID (B)(6) INITIAL RESULT = 3.87 MMOL/L; REPEAT RESULT = 0.94 MMOL/L. PATIENT (B)(6) (SID NOT PROVIDED) INITIAL RESULT = 3.5 MMOL/L; REPEAT RESULT - 0.7 MMOL/L. PATIENT (B)(6) (SID NOT PROVIDED) INITIAL RESULT = 2.6 MMOL/L; REPEAT RESULT = 1.0 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689731 ↗
• MalfunctionMay 13, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR ONE PATIENT. THE INITIAL PATIENT RESULT WAS 5.0 (UNIT OF MEASURE NOT PROVIDED), REPEATED 1.5. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821862 ↗
• MalfunctionOct 21, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: SID (B)(6) ON (B)(6) 2019 = 6.49 / 2.17 / 2.05 MG/DL; NEW TUBE= 2.01 MG/DL. CUSTOMERS NORMAL RANGE: (1.8-2.6 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9214509 ↗
• MalfunctionSep 19, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: SID (B)(6), (B)(6) 2019 = 6.49 / 2.17 / 2.05 MG/DL; NEW TUBE= 2.01 MG/DL. CUSTOMERS NORMAL RANGE: (1.8-2.6 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086245 ↗
• MalfunctionAug 26, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 3.0, REPEAT 0.7 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8933332 ↗
• MalfunctionJul 30, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED MAGNESIUM RESULTS WERE GENERATED FOR FIVE PATIENT SAMPLES TESTED ON THE ARCHITECT C4000 ANALYZER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SID (B)(6): 3.6 MG/DL, REPEAT 4.7/2.4 MG/DL, SID (B)(6): 4.1 MG/DL, REPEAT 1.9 MG/DL, SID (B)(6): 3.3 MG/DL, REPEAT 1.8 MG/DL, SID (B)(6): 5.3 MG/DL, REPEAT 2.0 MG/DL, SID (B)(6): 9.0 MG/DL, REPEAT 1.4 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842390 ↗
• MalfunctionJun 20, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): PT 2 INITIAL 6.95, REPEAT 3.4, 2.2. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8717218 ↗
• MalfunctionApr 24, 2019High Test Results; High Test Results

  THE CUSTOMER GENERATED FALSELY ELEVATED MAGNESIUM RESULT WHILE USING THE CLINICAL CHEMISTRY MAGNESIUM ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULT DATA (CUSTOMER REFERENCE RANGE FOR MG (1.6 - 2.6) MG/DL: ON (B)(6) 2019: INITIAL: 2.5 MG/DL, RETESTS 1.1 MG/DL AND 1.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546603 ↗
• MalfunctionApr 17, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS ON TWO PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 PT#1 = 7.8MG/DL / 2.1; PT#2 = 6.41 / 2.03MG/DL (NORMAL RANGE 1.3-2.3MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523453 ↗
• MalfunctionMar 19, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCREPANT MAGNESIUM RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): INITIAL 1.29, REPEATS 1.86, 1.23 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433156 ↗
• MalfunctionMar 13, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT OF 6.2 MG/DL WAS REPORTED FOR A PATIENT SAMPLE THAT RETESTED AT 2.6 MG/DL. A CORRECTED REPORT WAS ISSUED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416696 ↗
• MalfunctionMar 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY DEPRESSED URINE MAGNESIUM RESULTS WERE GENERATED WHILE USING THE MAGNESIUM URINE APPLICATION. THE FOLLOWING SIDS GENERATED RESULTS < 1.50 MG/DL: SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410245 ↗
• MalfunctionFeb 28, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT ANALYZER FOR TWO PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6): FIRST ARCHITECT = 2.1 / REPEATED ON SECOND ARCHITECT = 1.4 /1.3MG/DL (NORMAL RANGE 1.6 - 2.6MG/DL); SID (B)(6): FIRST ARCHITECT =2.0 / REPEAT ON SECOND ARCHITECT = 1.3 / 1.2MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378820 ↗
• MalfunctionFeb 19, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): SID (B)(6) INITIAL 9.4, REPEAT 2.1. SID (B)(6) INITIAL 6.3, REPEAT 1.6. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351660 ↗
• MalfunctionFeb 14, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED MAGNESIUM INITIAL RESULT OF 2.73 MMOL/L, WHEN PROCESSING ON THE ARCHITECT C16000. THE RETEST RESULTS WERE 0.75 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340754 ↗
• MalfunctionJan 28, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT MAGNESIUM RESULT. THE INITIAL SAMPLE GENERATED A RESULT OF 6.1 MG/DL. A NEW SAMPLE WAS COLLECTED AND GENERATED A RESULT OF 2.2 MG/DL. THE INITIAL SAMPLE WAS RETESTED AND GENERATED A RESULT OF 2.0 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283015 ↗
• MalfunctionJan 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED MAGNESIUM URINE CONTROLS SHIFTED LOW OUT OF RANGE WHILE USING THE ARCHITECT URINE MAGNESIUM ASSAY. DURING TROUBLESHOOTING THE CUSTOMER RETESTED PREVIOUSLY TESTED CAP SURVEY SAMPLES AND ALL THE MG URINE RESULTS WERE DECREASED FROM THE ORIGINAL RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8268894 ↗
• MalfunctionJan 15, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 11/30/2018, AN ABBOTT INTERNAL MAGNESIUM URINE LINEARITY STUDY CONFIRMED THE PERFORMANCE OF THE MAGNESIUM URINE APPLICATION (LIST NUMBERS 7D70-21 AND 7D70-31) EXCEEDS THE BIAS EXPECTATION OF 10% (OR 0.2 MEQ/L). AS A RESULT, THERE IS A POTENTIAL FOR FALSELY DEPRESSED RESULTS SINCE ALL URINE SAMPLES > 0.5 MEQ/L DEMONSTRATE DEPRESSED RECOVERY OF UP TO 37%. THERE IS NO IMPACT TO MAGNESIUM PLASMA/SERUM RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8247874 ↗
• MalfunctionDec 20, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT WAS GENERATED FOR A PATIENT SAMPLE. THE SAMPLE INITIALLY TESTED AT 6.2 MG/DL AND RETESTED AT 2.1 MG/DL. THE CUSTOMER'S NORMAL RANGE IS 1.8 - 2.8 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185777 ↗
• MalfunctionDec 18, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): SID (B)(6) INITIAL 9.4, REPEAT 2.1; SID (B)(6) INITIAL 6.3, REPEAT 1.6. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175070 ↗
• MalfunctionDec 7, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 6.1, REPEAT 3.2, 1.8 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143274 ↗
• MalfunctionDec 1, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT MAGNESIUM RESULTS. SAMPLE ID (B)(6) GENERATED ONE ELEVATED RESULT OF 7.4 MG/DL AND MULTIPLE LOWER RESULTS OF 1.9, 2.6 AND 2.1 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8122357 ↗
• MalfunctionNov 26, 2018High Readings; High Readings

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM (MG) RESULT GENERATED ON THE ARCHITECT ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2018 (B)(6) MG = 6.4MG/DL / PATIENT REDRAWN (B)(6) = 2.0MG/DL / THEN THE CUSTOMER RETESTED THE ORIGINAL SAMPLE 5X AND RESULTS WERE 2.0 OR 2.1MG/DL(NORMAL RANGE 1.6-2.6MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101465 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL 8.6, REPEAT 1.7, 1.7 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUT AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919762 ↗
• MalfunctionAug 6, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED RESULTS WHILE USING CLINICAL CHEMISTRY MAGNESIUM REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. (B)(6), INITIAL 5.4 MEQ/L, REPEAT 1.2 MEQ/L; (B)(6), INITIAL 6.1 MEQ/L, REPEAT 1.4 MEQ/L; (B)(6), INITIAL 6.1 MEQ/L, REPEAT 1.6, 1.5 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754305 ↗