ARCHITECT 2K43-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380740003302), received between Oct 3, 2023 and Jul 22, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED PERFORMANCE ISSUES DURING PREVIOUS PROFICIENCY SURVEYS AND QUALITY CONTROL ISSUE WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23 ON THE ARCHITECT I1000 PROCESSING MODULE, SN (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798446 ↗
• MalfunctionMay 17, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED THAT MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED TO BE DIFFERENT THAN EXPECTED AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST (B)(4), LOT 50808UN23 ON THE ARCHITECT I2000 PROCESSING MODULE, SN (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342704 ↗
• MalfunctionApr 17, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  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 02K43-25, LOT 50808UN23 ON THE ARCHITECT I2000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126823 ↗
• MalfunctionApr 2, 2024Product Quality Problem; Failure to Calibrate; Product Quality Problem; Failure to Calibrate

  THE CUSTOMER OBSERVED MICROPARTICLES IN THE MICROPARTICLES BOTTLES APPEARS TO BE DIFFERENT THAN EXPECTED AND ERROR CODE 1119 ASSAY (X) NUMBER (Y) CALIBRATION FAILURE, CURVE VALIDITY CHECK FAILED AFTER CALIBRATING INSTRUMENT WITH THE REAGENT LOT 50808UN23, LIST 02K43-25 ON THE ARCHITECT I1000 PROCESSING MODULE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020216 ↗
• MalfunctionApr 2, 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 ABBOTT QUALITY CONTROLS WAS OUT OF RANGE HIGH, RLU VALUES OF THE CALIBRATION CURVES WERE MUCH LOWER THAN PREVIOUS LOT AND MICROPARTICLES IN THE MICROPARTICLE REAGENT BOTTLE APPEARS TO BE SIGNIFICANTLY DIFFERENT WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST NUMBER 02K43-25, LOT NUMBER 50808UN23. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019874 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISION WITH MULTIPLE LEVELS OF QUALITY CONTROLS WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST NUMBER 02K43-25, LOT NUMBER 50808UN23. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940622 ↗
• MalfunctionMar 18, 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 BIO-RAD QUALITY CONTROLS WAS OUT OF RANGE LOW, CALIBRATION FAILURES AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST NUMBER 02K43-25, LOT NUMBER 50808UN23. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923926 ↗
• 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 LEVEL 2 FOR ABBOTT QUALITY CONTROLS WERE OUT OF RANGE HIGH, AND LEVEL 3 WAS OUT OF RANGE LOW AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED TO BE DIFFERENT THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT RESULTS AND PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921194 ↗
• MalfunctionMar 17, 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 LOW AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST NUMBER 02K43-25, LOT NUMBER 50808UN23. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919183 ↗
• MalfunctionMar 13, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED QUALITY CONTROLS RESULTS WERE OUT OF RANGE LOW WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. FOLLOWING QC DATA WAS PROVIDED. L1 29.6 (20.7¿38.5) L2 89.6 (71.7¿107) L3 227 (182¿273) QC DATA FROM THE IMPACTED LOT AND DIFFERENT LOT 50808UN23 DIFFERENT NEW REAGENT L1 29.6 (20.7¿38.5) 24.0 L2 89.6 (71.7¿107) 76.5 L3 227 (182¿273) 175.2 THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USERS¿ SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896234 ↗
• MalfunctionMar 13, 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 QUALITY CONTROLS RESULTS WERE OUT OF RANGE LOW AND CALIBRATION FAILURES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USERS¿ SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896040 ↗
• MalfunctionMar 12, 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 ERROR CODE 1119, VALIDITY CHECK FAILED, RLU WAS LOW FOR THE CALIBRATION AND QUALITY CONTROLS WERE OUT OF RANGE HIGH WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST (B)(4), LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USERS¿ SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889630 ↗
• MalfunctionMar 12, 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 RLU WAS LOW FOR THE CALIBRATION AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USERS¿ SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888697 ↗
• MalfunctionMar 12, 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 QUALITY CONTROLS RESULTS WERE OUT OF RANGE LOW, RLU WAS LOW FOR THE CALIBRATION AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888312 ↗
• MalfunctionMar 12, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED QUALITY CONTROLS (QC) RESULTS WERE OUT OF RANGE LOW WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THE CUSTOMER PROVIDED FOLLOWING DATA FOR QC. L1: 39.9UG/L, NORMAL 65 UG/L, L2 : 87.2 UG/L NORMAL 120 UG/L L3 : 188 UG/L NORMAL 270 UG/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887834 ↗
• MalfunctionMar 12, 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 MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL, LOW RLU DURING CALIBRATION AND BIO RAD QUALITY CONTROL WERE OUT OF RANGE LOW AND PATIENT COMPARISON WAS HIGH WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST (B)(4), LOT 50808UN23. THE FOLLOWING RESULTS WERE PROVIDED FOR SAMPLE COMPARISON BETWEEN 2 REAGENT LOT NUMBERS FOR MYOGLOBIN. 50808UN23 37319UN23 BIAS SID1: 36.3, 26.6 , -26.72%. SID2: 117.7, 65.3, -44.52%. SID3: 256.9, 154.1, -40.02%. SID4: 364.8, 206.3, -43.45%. SID5: 810.6, 552, -31.9%. COMPARISON WAS COMPLETED USING PATIENT SAMPLES FOR COMPARISON ONLY AND NOT FOR THE PATIENT MANAGEMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886330 ↗
• MalfunctionMar 11, 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 CALIBRATION FAILURE DUE TO LOW RLU WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST (B)(6), LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876930 ↗
• MalfunctionMar 11, 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 MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL, LOW RLU AFTER CALIBRATION AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874361 ↗
• MalfunctionMar 11, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED THAT MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL AND QUALITY CONTROL RESULTS WERE OUT OF RANGE HIGH COMPARED TO PACKAGE INSERT WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874161 ↗
• MalfunctionMar 11, 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 MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL, LOW RLU AFTER CALIBRATION AND QUALITY CONTROL RESULTS ISSUES WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874105 ↗
• MalfunctionMar 11, 2024Product Quality Problem; Failure to Calibrate; Product Quality Problem; Failure to Calibrate

  THE CUSTOMER OBSERVED ERROR CODE 1119 ASSAY (X) NUMBER (Y) CALIBRATION FAILURE, CURVE VALIDITY CHECK FAILED AND MICROPARTICLES IN THE MICROPARTICLES BOTTLE APPEARED LIGHTER THAN USUAL WHILE USING ARCHITECT STAT MYOGLOBIN REAGENT LIST 02K43-25, LOT NUMBER 50808UN23. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873981 ↗
• MalfunctionFeb 29, 2024Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results; Low Test Results; Product Quality Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results; Low Test Results

  ABBOTT HAS IDENTIFIED ARCHITECT STAT MYOGLOBIN, LIST NUMBER 02K43-25, LOT NUMBER 50808UN23 DID NOT MEET THE MINIMUM MICROPARTICLE CONCENTRATION LABEL CLAIM OF 0.10% SOLIDS DUE TO A FORMULATION ISSUE. CUSTOMERS OBSERVED QUALITY CONTROL (QC), CALIBRATION, PRECISION ISSUES, AND THE MICROPARTICLE INSIDE THE BOTTLE APPEARED LIGHTER IN COLOR. AN INTERNAL STUDY SHOWED ELEVATED IMPRECISION FOR LOT NUMBER 50808UN23. ARCHITECT STAT MYOGLOBIN, LIST NUMBER 02K43-20, LOT NUMBER 60104UN23 USED THE SAME MICROPARTICLE CONCENTRATE AS LOT NUMBER 50808UN23, HOWEVER NO PERFORMANCE ISSUE WAS DEMONSTRATED. THIS LOT WAS MIXED PROPERLY BUT THE MATERIAL THAT WAS USED FOR FORMULATION WAS TOO CONCENTRATED. THERE IS POTENTIAL FOR DELAY IN RESULTS AS WELL AS FALSELY DEPRESSED OR FALSELY ELEVATED RESULTS WHEN USING LOT 50808UN23, HOWEVER THERE HAVE BEEN NO REPORTED DELAY OF RESULTS OR ADVERSE IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE. THERE IS NO POTENTIAL FOR DELAY OF RESULTS OR INCORRECT RESULTS WHEN USING LOT 60104UN23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808682 ↗
• MalfunctionOct 3, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT MYOGLOBIN RESULT FOR A MALE PATIENT, WHO HAD NO MYOCARDIAL INFARCTION SYMPTOMS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS <154.9 NG/ML): INITIAL RESULT WAS >1200, 1:10 DILUTION RESULT WAS 4192 NG/ML. THE SAMPLE WAS TESTED WITH A MICROPOINT TEST, AND THE RESULT WAS 0.15 NG/ML, REFERENCE RANGE IS <0.3 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A NANJING GETEIN BIOTECH POCT INSTRUMENT, AND THE RESULT WAS >600 NG/ML. THE SAMPLE WAS SENT OUT FOR TESTING USING A ROCHE ASSAY AND THE RESULT WAS 1751.0 NG/ML, REFERENCE RANGE IS 28-72 NG/ML. THE SAMPLE WAS ALSO TESTED WITH A BECKMAN ASSAY AND THE RESULT WAS 2187.9 NG/ML. IT WAS NOTED THAT BASED ON THE ELEVATED RESULTS, THE PATIENT RECEIVED AN ELECTROCARDIOGRAM AND INFUSION THERAPY. THE PATIENT HAD NO SYMPTOMS AND HAD SINCE BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864799 ↗