ARCHITECT 08K2812Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740145262), received between Jun 20, 2019 and Nov 8, 2019 — classified as 12 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. May 24, 2019Terminated

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

   Z-2079-2019 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFTING LOW WHILE USING ARCHITECT BNP CONTROL LOT 44K82818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9296060 ↗
• 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 9100659 ↗
• MalfunctionAug 7, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A SHIFT IN CONTROLS WHILE USING ARCHITECT BNP CONTROLS LOT 44K79518. THE CUSTOMER INDICATED THEY MAY HAVE HAD FALSE RESULTS REPORTED HOWEVER HAVE HAD NO RESULTS QUESTIONED BY THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8869427 ↗
• MalfunctionAug 7, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A SHIFT IN CONTROLS WHILE USING ARCHITECT BNP CONTROLS LOT 44K81118. THE CUSTOMER INDICATED THEY MAY HAVE HAD FALSE RESULTS REPORTED HOWEVER HAVE HAD NO RESULTS QUESTIONED BY THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8869425 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS OUT OF RANGE WHILE USING ARCHITECT BNP CONTROL LOT 44K82818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8796754 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS OUT OF RANGE WHILE USING ARCHITECT BNP CONTROL LOT 44K79518. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8796753 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFT HIGH AND OUT OF RANGE WHILE USING ARCHITECT BNP CONTROL LOT 44K82818. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8796741 ↗
• MalfunctionJul 14, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED ABBOTT CONTROLS SHIFTING LOW AND OUT OF RANGE WHILE USING THE ARCHITECT BNP CONTROL LOT NUMBER 44K81118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8787631 ↗
• MalfunctionJul 1, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED SURVEY RESULTS AND CONTROLS SHIFTED HIGH AND OUT OF RANGE WHILE USING ARCHITECT BNP CONTROL LOT 44K81118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8749433 ↗
• MalfunctionJun 28, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED ABBOTT CONTROLS OUT OF RANGE WHILE USING ARCHITECT CONTROL LOT 44K81118. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8745483 ↗
• MalfunctionJun 28, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED BIORAD CONTROLS SHIFT HIGH ON THE ARCHITECT BNP ASSAY. THE CUSTOMER INDICATED THE ASSAY WAS CALIBRATED WITH CONTROL LOT 44K82018. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8743585 ↗
• MalfunctionJun 20, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED ABBOTT ARCHITECT BNP CONTROL LOT 44K82818 SHIFTED UP AFTER CALIBRATION. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8717455 ↗