ARCHITECT 9D28-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740019327), received between Aug 29, 2018 and Dec 5, 2018 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 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. Aug 28, 2018Terminated

   There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

   Z-1296-2019 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED CHLORIDE (CL) RESULTS AND ANION GAP OUT OF RANGE WHILE USING THE ARCHITECT C8000 ANALYZER ICT MODULE. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. THE CUSTOMER USES CHLORIDE NORMAL RANGE 98 TO 107 MMOL/L. PER THE ICT DILUENT PRODUCT PACKAGE INSERT, ANION GAP VALUES ARE CALCULATED AS SODIUM (NA) MINUS THE SUM OF CARBON DIOXIDE (CO2) AND CHLORIDE (CL). PATIENT 1 INITIAL 144 MMOL/L, REPEAT USING ANOTHER ANALYZER 106 MMOL/L, REPEAT USING THE SAME ANALYZER AFTER CLEANING 113 MMOL/L. PATIENT 2 (SID (B)(6)) INITIAL 114 MMOL/L, REPEAT USING ANOTHER ANALYZER 106 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135214 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED BIORAD LEVEL 2 CONTROLS OUT OF RANGE HIGH FOR CHLORIDE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899560 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE ACCOUNT OBSERVED FALSELY DEPRESSED ARCHITECT CHLORIDE RESULTS CAUSING NEGATIVE ANION GAPS FOR PATIENT SAMPLES. THE ISSUE OCCURRED WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326343 ON THE ARCHITECT C8000. THE RESULT LOG SHOWED CHLORIDE RESULTS RANGING FROM 105 TO 110 MMOL/L. THE ICT MODULE WAS REPLACED FOR RESOLUTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7899313 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A SHIFT IN CHLORIDE SLOPE AND QC SHIFTED OUT OF RANGE HIGH WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326368) FOR THE CHLORIDE ASSAY. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899265 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED CHLORIDE QC SHIFTED UP AND OUT OF RANGE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326392). NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899215 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED CHLORIDE CONTROLS SHIFTED HIGH OUT OF RANGE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326380). NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899111 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED CHLORIDE QC SHIFTED HIGH OUT OF RANGE WHILE USING THE ARCHITECT ICT MODULE, LIST NUMBER 9D28-03, LOT NUMBER 180326328. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899051 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A SHIFT IN THE CALIBRATION SLOPE AND BIORAD LEVEL 3 CONTROLS OUT OF RANGE HIGH FOR CHLORIDE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326332) FOR THE CHLORIDE ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899021 ↗
• MalfunctionSep 21, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A SHIFT IN THE CALIBRATION SLOPE AND BIORAD LEVEL 3 CONTROLS OUT OF RANGE HIGH FOR CHLORIDE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326331) FOR THE CHLORIDE ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7899020 ↗
• MalfunctionSep 18, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A SHIFT IN BIORAD CONTROLS WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326375) FOR THE CHLORIDE ASSAY. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7885832 ↗
• MalfunctionSep 17, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED HIGHER THAN EXPECTED CHLORIDE QC RESULTS, WHEN USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326396). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880346 ↗
• MalfunctionSep 17, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LEVEL II QC AND PATIENT RESULTS FOR THE CHLORIDE ASSAY WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326391). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880327 ↗
• MalfunctionSep 14, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED LEVEL 2 QC SHIFTING HIGH FOR CHLORIDE WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7878429 ↗
• MalfunctionSep 13, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN INCREASE IN ELEVATED CHLORIDE RESULTS WHILE USING THE ARCHITECT ICT MODULE (LIST NUMBER 9D28-03, LOT NUMBER 180326). NO SPECIFIC RESULTS WERE PROVIDED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874430 ↗
• MalfunctionAug 29, 2018High Test Results; High Test Results

  ABBOTT LABORATORIES HAS CONFIRMED HIGHER THAN EXPECTED SERUM OR PLASMA CHLORIDE RESULTS WHEN USING ARCHITECT ICT MODULE, LN 09D28-03, LOT NUMBER 180326. BASED ON AN ANALYSIS OF QC DATA FROM EXISTING CUSTOMERS, THE RESULTS GENERATED USING THIS LOT NUMBER MAY BE UP TO 6.2% HIGHER THAN EXPECTED. THIS QC ANALYSIS DOES NOT INDICATE AN ISSUE WITH URINE CHLORIDE RESULTS. ADDITIONALLY, SINCE THIS ISSUE ONLY IMPACTS THE CHLORIDE ELECTRODE ELEMENT OF THE ICT MODULE, POTASSIUM AND SODIUM RESULTS ARE NOT IMPACTED. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT DUE TO THIS ISSUE. HOWEVER, THERE IS A POTENTIAL TO GENERATE FALSELY ELEVATED SERUM OR PLASMA CHLORIDE RESULTS. THERE IS ALSO THE POTENTIAL TO DELAY THE REPORTING OF CHLORIDE ICT RESULTS DUE TO THE TIME REQUIRED FOR THE USER TO ATTEMPT TROUBLESHOOTING OF THE ISSUE WITH FALSELY ELEVATED SERUM CHLORIDE QUALITY CONTROL RESULTS.

  Patient problems: No Patient Involvement

  MAUDE report 7830570 ↗