ARCHITECT 08K2803Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00380740145255), received between Jun 10, 2019 and Mar 16, 2020 — classified as 93 malfunctions.

The most frequently reported specific device problem is “High Test Results” (89 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. May 24, 2019Terminated

   Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

   Z-2078-2019 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE LEVELS OF NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79418. NO DISCREPANT RESULTS WERE REPORTED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9835424 ↗
• MalfunctionJan 7, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED CAP BNP SURVEY RESULTS SHIFTING HIGH WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K82018. THE CUSTOMER FURTHER INDICATED ONE OF THE SURVEY SAMPLES WAS OUT OF RANGE HIGH. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9559184 ↗
• MalfunctionDec 11, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K81018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9453485 ↗
• MalfunctionOct 21, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9215769 ↗
• MalfunctionOct 2, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9144640 ↗
• MalfunctionSep 20, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTTT CONTROLS LOT 44K81118 AND BIORAD CONTROLS SHIFTING HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K81018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9100658 ↗
• MalfunctionSep 20, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9097381 ↗
• MalfunctionSep 20, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9097370 ↗
• MalfunctionSep 9, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8976464 ↗
• MalfunctionAug 23, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8926862 ↗
• MalfunctionAug 23, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79418. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8924988 ↗
• MalfunctionAug 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8901822 ↗
• MalfunctionAug 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8901488 ↗
• MalfunctionAug 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K81018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8901461 ↗
• MalfunctionAug 13, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A SHIFT IN ABBOTT CONTROLS WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79418. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8889912 ↗
• MalfunctionAug 7, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED LOW CONTROL SHIFT UP WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8869911 ↗
• MalfunctionAug 7, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFT HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8869717 ↗
• MalfunctionAug 5, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A SHIFT IN PATIENT RESULTS WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THE CUSTOMER PERFORMED CORRELATION USING PATIENT SAMPLES WITH THE OLD CALIBRATOR LOT 44K82018 AND THE NEW CALIBRATOR LOT 44K86819 AND PROVIDED THE FOLLOWING RESULTS (PG/ML). SAMPLE 1: LOT 44K82018 212.4 AND LOT 44K86819 195.3; SAMPLE 2: LOT 44K82018 339.8 AND LOT 44K86819 223.0; SAMPLE 3: LOT 44K82018 121.0 AND LOT 44K86819 106.8; SAMPLE 4: LOT 44K82018 <10 AND LOT 44K86819 <10; SAMPLE 5: LOT 44K82018 84.0 AND LOT 44K86819 72.1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860980 ↗
• MalfunctionAug 5, 2019High Test Results; High Test Results

  THE CUSTOMER OBTAINED FALSELY ELEVATED AND FAILING (B)(6) SURVEY RESULTS WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. SAMPLE (B)(6) GENERATED A RESULT OF 1319.6 WITH AN EXPECTED RANGE OF 789 TO 1239.6 AND SAMPLE (B)(6) GENERATED A RESULT OF >5000 WITH AN EXPECTED RANGE OF 3579.0 TO 4928.7. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8860955 ↗
• MalfunctionJul 22, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K81018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8811899 ↗
• MalfunctionJul 22, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8811896 ↗
• MalfunctionJul 17, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT BNP RESULTS WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79418. THE CUSTOMER PROVIDED THE FOLLOWING COMPARISON RESULTS: SAMPLE ID (B)(6): 299 NG/L ON THE COMPLAINT LOTS AND 209 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 4917 NG/L ON THE COMPLAINT LOTS AND 4066 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 3420 NG/L ON THE COMPLAINT LOTS AND 2681 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 1992 NG/L ON THE COMPLAINT LOTS AND 1351 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 1105 NG/L ON THE COMPLAINT LOTS AND 850 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 62 NG/L ON THE COMPLAINT LOTS AND 47 NG/L ON A NEW LOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797646 ↗
• MalfunctionJul 17, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT BNP RESULTS WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K81018. THE CUSTOMER PROVIDED THE FOLLOWING COMPARISON RESULTS: SAMPLE ID (B)(6): 299 NG/L ON THE COMPLAINT LOTS AND 209 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 4917 NG/L ON THE COMPLAINT LOTS AND 4066 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 3420 NG/L ON THE COMPLAINT LOTS AND 2681 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 1992 NG/L ON THE COMPLAINT LOTS AND 1351 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 1105 NG/L ON THE COMPLAINT LOTS AND 850 NG/L ON A NEW LOT; SAMPLE ID (B)(6): 62 NG/L ON THE COMPLAINT LOTS AND 47 NG/L ON A NEW LOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797635 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS OUT OF RANGE WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K81018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8796761 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79418. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8796751 ↗