ARCHITECT 8K28-02Recalls & reported problems
Abbott Laboratories · ARCHITECT BNP Calibrators · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Abbott ARCHITECT BNP calibrator, a reference material used to set up the BNP heart test, has 115 adverse event reports on file. Most describe control results reading high or out of range, and the reports note that no incorrect patient results were reported. The reports include no deaths and no injuries. There was 1 recall, now closed, which began in May 2019 over a time-related drift in patient and control BNP results.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 115
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00380740017460), received between Jun 12, 2019 and Jan 21, 2020 — classified as 115 malfunctions.
The most frequently reported specific device problem is “High Test Results” (114 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
- 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
Device problems
- High Test Results114
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Patient Involvement107
- No Known Impact Or Consequence To Patient8
Recent adverse event reports
The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2020High Test Results; High Test Results
THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9612735 ↗MalfunctionNov 8, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED LEVEL 1 BIORAD CONTROLS WERE OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82618. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9296030 ↗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 44K82618. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9215716 ↗MalfunctionOct 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED 4 OUT OF 5 PROFICIENCY SAMPLES FAILED WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9215655 ↗MalfunctionOct 1, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82118 . THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9141971 ↗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 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8901458 ↗MalfunctionAug 13, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS SHIFT HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8889909 ↗MalfunctionAug 7, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED LOW BIORAD CONTROL SHIFT HIGH AND OUT OR RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8869531 ↗MalfunctionAug 5, 2019High Test Results; High Test Results
THE CUSTOMER OBTAINED A FALSELY ELEVATED BIORAD EQAS SURVEY RESULT WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K82118. THE SAMPLE GENERATED 12247.2 NG/L AND THE EXPECTED RESULT WAS 8457 NG/L. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8861057 ↗MalfunctionJul 31, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8846135 ↗MalfunctionJul 24, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED MAS CARDIO QC AND PATIENT RESULTS SHIFTED UP WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8823615 ↗MalfunctionJul 23, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS OUT OF RANGE HIGH WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8818334 ↗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 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8811928 ↗MalfunctionJul 22, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED NON-ABBOTT AND ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82618. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8811926 ↗MalfunctionJul 22, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K80818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8811862 ↗MalfunctionJul 17, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFT HIGH AND OUT OF RANGE WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318 .THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8797649 ↗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 44K80818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8796750 ↗MalfunctionJul 14, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED A SHIFT IN CONTROLS WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8787646 ↗MalfunctionJul 14, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFTING HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K82118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8787644 ↗MalfunctionJul 14, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFT HIGH AND OUT OF RANGE WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8787618 ↗MalfunctionJul 14, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8787614 ↗MalfunctionJul 14, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED CONTROLS SHIFTING HIGH AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K80818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8787610 ↗MalfunctionJul 12, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTED HIGH WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8786695 ↗MalfunctionJul 12, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTED HIGH WHILE USING ARCHITECT BNP CALIBRATOR LOT 44K79318. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8786685 ↗MalfunctionJul 12, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFTING HIGH WHILE USING THE ARCHITECT BNP CALIBRATOR LOT 44K80818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8785855 ↗
Other CALIBRATOR, SECONDARY devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 reports
- ARCHITECT 8K28-11Abbott Laboratories · CALIBRATOR, SECONDARY1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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