ARCHITECT 2K43-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740003296), received between May 10, 2021 and Sep 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Feb 21, 2024Open, Classified

   The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.

   Z-1476-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Low Test Results

  The customer observed falsely depressed ARCHITECT Myoglobin results for four samples. The following data was provided:Sample 1 initial ARCHITECT Myoglobin result 12 ng/mL, retest 40 ng/mL,Sample 2 initial ARCHITECT Myoglobin result 9.2 ng/mL, retest 31.4 ng/mL,Sample 3 initial ARCHITECT Myoglobin result 91 ng/mL, retest 412.1 ng/mL,Sample 4 initial ARCHITECT Myoglobin result 70 ng/mL, retest 336.6 ng/mL. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803312 ↗
• MalfunctionJun 21, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER OBSERVED THAT QUALITY CONTROL WERE OUT OF RANGE HIGH FOR ALL THREE LEVELS WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I1000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579989 ↗
• MalfunctionJun 20, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER OBSERVED THAT QUALITY CONTROL WERE OUT OF RANGE HIGH FOR ALL THREE LEVELS WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I1000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579218 ↗
• MalfunctionJun 4, 2024Product Quality Problem; Failure to Calibrate; Product Quality Problem; Failure to Calibrate

  THE CUSTOMER OBSERVED THAT MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23 ON THE ARCHITECT I2000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461962 ↗
• MalfunctionMar 18, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED THAT BIO-RAD QUALITY CONTROLS WAS OUT OF RANGE HIGH AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED DIFFERENT THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST NUMBER 02K43-20, LOT NUMBER 60104UN23. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925017 ↗
• MalfunctionMar 14, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate

  THE CUSTOMER OBSERVED THAT QUALITY CONTROLS (QC) WERE OUT OF RANGE LOW AFTER USE OF ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23. THE CUSTOMER PROVIDED FOLLOWING DATA FOR THE QC. QC1 55.9 79.95 WITH THE RANGE 63.96-95.94 NG/ML QC2 298.3 449.89 WITH THE RANGE 359.93-539.85 NG/ML SAMPLE COMPARISON RECOVERED WITHIN RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905298 ↗
• MalfunctionMar 14, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate

  THE CUSTOMER OBSERVED THAT QUALITY CONTROLS (QC) WERE OUT OF RANGE LOW AFTER USE OF ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-20, LOT 60104UN23. THE CUSTOMER PROVIDED FOLLOWING DATA FOR THE QC. LOW LEVEL: 48.9 NG/ML, 47.8 NG/ML WITH THE RANGE 60.2-83.0 NG/ML AND HIGH LEVEL WAS 257 NG/ML WITH THE RANGE 339-459 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904133 ↗
• MalfunctionMay 10, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL=1003.7 NG/ML / REPEATED DUE TO QUESTIONED BY PHYSICIAN =51 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801795 ↗