Dimension Clinical Chemistry System A1C Kit 10720883Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414006659), received between Mar 2, 2020 and May 15, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED DIMENSION HEMOGLOBIN A1C (HBA1C) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT GA6344. THE CUSTOMER USED AN INVALID CALIBRATION WHICH RESULTED IN ABOVE ASSAY RANGE RESULT ACCOMPANIED BY AN INSTRUMENT ERROR. THE OPERATOR¿S GUIDE/INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS WAS NOT FOLLOWED, AS THE CUSTOMER DISREGARDED THE ERROR MESSAGE AND DISCORDANT HBA1C PATIENT SAMPLE RESULT WAS REPORTED FOR ONE (1) PATIENT SAMPLE. THE RESULT WAS NOT QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS SUBSEQUENTLY RETESTED ON THE ORIGINAL ANALYZER WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND WAS ISSUED ON CORRECTED REPORT TO THE PHYSICIAN. THERE WERE NO ALLEGATIONS OF PATIENT HARM DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191966 ↗
• MalfunctionMay 15, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED DIMENSION HEMOGLOBIN A1C (HBA1C) RESULTS WHICH WERE DISCORDANT RELATED TO REPEAT TESTING WHEN USING LOT: GA6344. THE CUSTOMER USED AN INVALID CALIBRATION WHICH RESULTED IN ABOVE ASSAY RANGE RESULTS ACCOMPANIED BY AN INSTRUMENT ERROR. THE OPERATOR¿S GUIDE/INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS WERE NOT FOLLOWED, AS THE CUSTOMER DISREGARDED THE ERROR MESSAGES AND DID NOT PERFORM THE REQUIRED MANUAL DILUTION PROCEDURE PER THE IFU. DISCORDANT HBA1C PATIENT SAMPLE RESULTS WERE REPORTED FOR TWO (2) PATIENT SAMPLES. FOR ONE (1) PATIENT SAMPLE WITH SID: (B)(6), THE DISCORDANT RESULT WAS QUESTIONED BY THE PHYSICIAN WHICH CONTRIBUTED TO THE CANCELLATION OF A SCHEDULED SURGERY. THE PATIENT WAS RETESTED AT AN ALTERNATE LABORATORY WHICH YIELDED A LOWER (NORMAL) RESULT. THE INITIAL PATIENT SAMPLE WAS SUBSEQUENTLY RETESTED ON THE ORIGINAL ANALYZER USING THE INVALID CALIBRATION AND CONTINUED TO YIELD A HIGHER RESULT. FOR THE OTHER PATIENT SAMPLE, THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN BUT WAS NOT QUESTIONED. THE PATIENT SAMPLE WAS SUBSEQUENTLY RETESTED ON THE ORIGINAL ANALYZER WHICH YIELDED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED COR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187212 ↗
• MalfunctionApr 26, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HEMOGLOBIN A1C ASSAY (A1C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM. THE REPROCESSED RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPROCESSED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED HEMOGLOBIN A1C ASSAY (A1C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993495 ↗
• MalfunctionApr 26, 2026High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HEMOGLOBIN A1C ASSAY (A1C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS SENT TO AN ALTERNATE LAB AND REPROCESSED ON A NON-SIEMENS SYSTEM. THE REPROCESSED RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPROCESSED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED HEMOGLOBIN A1C ASSAY (A1C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993489 ↗
• MalfunctionMar 2, 2020High Test Results; High Test Results

  A FALSELY ELEVATED HEMOGLOBIN A1C (A1C) RESULT WAS OBTAINED ON A PATIENT WHOLE BLOOD SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AFTER RECALIBRATION OF THE ASSAY AND DILUTION OF THE SAMPLE. A LOWER RESULT WAS OBTAINED AND A CORRECTED RESULT WAS ISSUED. THE ACCOUNT STATED THAT A CARDIAC CATHETERIZATION WAS DELAYED. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED AIC RESULT OR THE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774734 ↗
• MalfunctionMar 2, 2020High Test Results; High Test Results

  A FALSELY ELEVATED HEMOGLOBIN A1C (A1C) RESULT WAS OBTAINED ON A PATIENT WHOLE BLOOD SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AFTER RECALIBRATION OF THE ASSAY AND DILUTION OF THE SAMPLE. A LOWER RESULT WAS OBTAINED AND A CORRECTED RESULT WAS ISSUED. THE ACCOUNT STATED THAT A CARDIAC CATHETERIZATION WAS DELAYED. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED AIC RESULT OR THE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774733 ↗