ARCHITECT 4P52-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740102722), received between Jun 26, 2019 and Jul 12, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A CALIBRATION FAILURE WHILE USING THE ARCHITECT HBA1C CALIBRATOR LOT 54582UQ02.THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8785830 ↗
• MalfunctionJun 26, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A SHIFT IN CONTROL WHILE USING THE ARCHITECT HBA1C CALIBRATOR, LIST 04P52-01, LOT 54582UQ02. NO DISCREPANT PATIENT RESULTS WERE GENERATED. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8734320 ↗
• MalfunctionJun 26, 2019Failure to Calibrate; High Test Results; Failure to Calibrate; High Test Results

  THE CUSTOMER RECEIVED ERROR CODE 1353 CALIBRATION FAILURE, CALIBRATION FACTOR OUT OF RANGE AND CONTROLS OUT OF RANGE HIGH WHILE USING THE ARCHITECT HBA1C CALIBRATOR, LIST 04P52-01, LOT 54582UQ02. NO DISCREPANT PATIENT RESULTS GENERATED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8734315 ↗
• MalfunctionJun 26, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT HBA1C RESULT FOR ONE PATIENT SAMPLE AND VARIATION OF CONTROL RESULTS WHILE USING ARCHITECT HBA1C CALIBRATOR, LIST 04P52-01, LOT 54582UQ02. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 11.1% AND RETEST TWO DAYS LATER GENERATED 5.2%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8734306 ↗