ARCHITECT 2K43-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380740003272), received between Mar 17, 2022 and Jun 10, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (10 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. Mar 8, 2022Open, Classified

   This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

   Z-0891-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER OBSERVED QUALITY CONTROLS OUT OF RANGE WHILE USING THE ARCHITECT MYOGLOBIN CALIBRATOR LOT 166000. AFTER CHANGING TO A NEW LOT OF CALIBRATORS, THE QUALITY CONTROL RESULTS WERE IN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657185 ↗
• MalfunctionMay 17, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED THAT AFTER THE FIELD SERVICE REPRESENTATIVE (FSR) WAS ONSITE AND REPLACED PARTS ON THE ARCHITECT I2000SR ANALYZER, THE CUSTOMER RAN TECHNOPATH QUALITY CONTROL (QC) ON MYOGLOBIN AND NOTED THAT THE RESULTS WERE OUT OF RANGE HIGH PER THE PACKAGE INSERT RANGES WHILE USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE FSR REVIEWED THE DATA AND FOUND THAT THE QC WAS IN RANGE BUT HIGHER SINCE SERVICE WAS PERFORMED ON THE INSTRUMENT. IT WAS ALSO NOTED THAT THE ASSAY HAD NOT BEEN CALIBRATED SINCE 11FEB2022. THE FSR RECOMMENDED TO THE CUSTOMER THAT THE ASSAY SHOULD BE CALIBRATED DUE TO THE PARTS BEING REPLACED DURING A PREVIOUS SERVICE CALL. IT WAS RECOMMENDED TO CALIBRATE THE ASSAY AND RUN 2 REPLICATES OF EACH LEVEL OF CONTROLS; THIS RESOLVED THE CUSTOMER ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14416297 ↗
• MalfunctionMay 16, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER OBSERVED QUALITY CONTROLS (QC) WERE OUT OF RANGE HIGH PEER RANGE FROM APRIL ON MULTIPLE ASSAYS. EXAMPLES PROVIDED BY THE CUSTOMER WERE THAT TROPONIN AND MYOGLOBIN WERE OUT OF RANGE. THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND CONDUCTED TROUBLESHOOTING OF THE CUSTOMER¿S ARCHITECT I2000SR ANALYZER. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THE MYOGLOBIN QC LEVEL 3 WAS STILL OUT OF PACKAGE INSERT RANGE WHEN USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER SWITCHED TO A DIFFERENT CALIBRATOR LOT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408301 ↗
• MalfunctionApr 27, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED THE ABBOTT CONTROLS WERE OUT OF RANGE HIGH ON ALL LEVELS WHILE USING THE ARCHITECT MYOGLOBIN CALIBRATOR, LOT 166000. THE CUSTOMER REPORTED THAT THE ISSUE BEGAN IMMEDIATELY AFTER CALIBRATION. THE CUSTOMER'S ISSUE WAS RESOLVED WITH THE USE OF A DIFFERENT CALIBRATOR LOT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218304 ↗
• MalfunctionApr 22, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED THE MYOGLOBIN QUALITY CONTROL (QC) WERE POOR WITH THE USE OF THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE BIO-RAD QC WAS USED AND THE FOLLOWING DATA WAS PROVIDED: L1 TARGET VALUE: 45, ALLOWABLE RANGE: 36.9-53.1, TEST RESULT: 61.1NG/ML. L2 TARGET VALUE: 133, ALLOWABLE RANGE: 109-157, TEST RESULT: 177 NG/ML. L3 TARGET VALUE: 298, ALLOWABLE RANGE: 244-352, TEST RESULT: 370 NG/ML. THE QC WAS NOTED TO BE HIGH. THE CUSTOMER SWITCHED TO A NEW CALIBRATOR LOT AND CALIBRATION PASSED AND QC WERE IN RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190188 ↗
• MalfunctionApr 22, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER OBSERVED QUALITY CONTROLS (QC) WERE SKEWED HIGH WHEN USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE FOLLOWING VALUES WERE PROVIDED: 111.7 NG/ML AND 694.5 NG/ML. (QC RANGES: 64-82 NG/ML 470-580 NG/ML). THE CALIBRATOR LOT WAS CHANGED, AND THE VALUES WERE WITHIN RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14185742 ↗
• MalfunctionApr 12, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER OBSERVED CONTROLS OUT OF RANGE DURING A CALIBRATION RUN WHEN USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE CALIBRATOR LOT WAS CHANGED, AND THE VALUES WERE WITHIN CONTROL RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087775 ↗
• MalfunctionApr 8, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED THE MYOGLOBIN QUALITY CONTROL (QC) WERE HIGH WHEN USING THERMOFISHER AND ABBOTT CONTROLS, SINCE CALIBRATING WITH THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE FOLLOWING VALUES WERE PROVIDED: L1: 42 FOR AN EXPECTED 34 NG/ML, L2: 178 FOR AN EXPECTED 138, [LOW: 70.3; MEDIUM: 340; HIGH: 905.3]. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052049 ↗
• MalfunctionApr 7, 2022Calibration Problem; Calibration Problem

  THE CUSTOMER REPORTED THAT THE MYOGLOBIN QUALITY CONTROLS (QC) USING BIO-RAD 87810 HAD VALUES SHIFTING DOWN ON BOTH LEVELS, AND AFTER CALIBRATING, LEVEL 1 WAS OK AND LEVEL 2 HAD HIGH VALUES WHILE USING THE ARCHITECT STAT MYOGLOBIN CALIBRATOR, LOT 166000. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022 (NG/ML), L1= 32.8, L2= 115, AFTER CALIBRATING ON (B)(6) 2022 (NG/ML), L1 = 43.4, L2 = 161.9, BIO-RAD RANGE 87810 (NG/ML), L1 RANGE (33.4 - 49.9), L2 RANGE (91.8 - 150). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044933 ↗
• MalfunctionMar 17, 2022Calibration Problem; Calibration Problem

  ABBOTT RECEIVED NOTIFICATION FROM THE THIRD PARTY MANUFACTURER (TPM), THERMO FISHER SCIENTIFIC (B)(4), THAT THE ARCHITECT STAT MYOGLOBIN CALIBRATOR KIT (LIST NUMBER 02K43-01, LOT 166000) DID NOT MEET SPECIFICATION FOR HIGH CONTROL RECOVERY AT THE 52-WEEK STABILITY TIMEPOINT. WHEN A CALIBRATION IS PERFORMED WITH THIS LOT, CONTROLS MAY EXCEED THE SPECIFIED RANGE IN THE INSTRUCTIONS FOR USE (IFU). STABILITY TESTING BY THERMO FISHER SCIENTIFIC SHOWS THAT THERE ARE NO OTHER CALIBRATOR LOTS WITH RESULTS THAT ARE OUT OF RANGE. THERE IS NO IMPACT ON PATIENT RESULTS WHEN THE CALIBRATION IS SUCCESSFUL AND THE CONTROLS ARE WITHIN RANGE. THE ISSUE DOES HAVE THE POTENTIAL FOR A DELAY OF PATIENT RESULTS DUE TO THE INABILITY TO GENERATE A VALID CALIBRATION CURVE. THERE HAS BEEN NO REPORTED DELAY OF RESULTS OR ADVERSE IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792887 ↗