Dimension® Flex® reagent cartridge CRE2 10872079Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414595009), received between Oct 21, 2021 and Apr 7, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 18, 2026Class IIOpen, Classified

   Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

   Z-1980-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797148 ↗
• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED A HIGHER RESULT. THE REPEAT RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO AN ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797147 ↗
• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797144 ↗
• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797143 ↗
• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON TEN PATIENT SAMPLES ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED HIGHER RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797135 ↗
• MalfunctionMar 31, 2026Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPROCESSED ON A NON-SIEMENS SYSTEM. THE REPROCESSED RESULT WAS HIGHER THAN THE ERRONEOUS RESULT AND WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED BY REPORTING THE REPROCESSED RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743756 ↗
• MalfunctionMar 11, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS A POTENTIALLY ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT ON ONE (1) PATIENT SAMPLE WAS OBTAINED DURING A COMPARISON STUDY ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE POTENTIALLY ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED FOR TROUBLESHOOTING PURPOSES USING A DIFFERENT LOT OF CREATININE (CRE2) ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND OBTAINED A HIGHER RESULT, WHICH WAS NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER PERFORMED THE COMPARISON STUDY FOR TROUBLESHOOTING PURPOSES AND IS NOT ALLEGING ANY OF THE RESULTS TO BE DISCORDANT. IT IS UNKNOWN WHICH RESULT IS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY ERRONEOUSLY DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576050 ↗
• MalfunctionJul 17, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT WITH A DELTA CHECK FLAG ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM AND ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE (CRE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760642 ↗
• MalfunctionOct 21, 2021High Test Results; High Test Results

  AN ELEVATED CREATININE (CRE2) PATIENT SAMPLE RESULT WAS OBTAINED ON TWO DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEMS WHEN COMPARED TO A CREATININE RESULT ON THE SAME SAMPLE PROCESSED WITH AN ALTERNATE METHODOLOGY ON AN ALTERNATE SIEMENS SYSTEM. THE RESULTS FROM BOTH SYSTEMS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE DIFFERENCE IN RESULTS. THE CUSTOMER DOES NOT CONSIDER ANY OF THE RESULTS TO BE DISCORDANT. NO CORRECTED REPORTS WERE ISSUED. THE PATIENT WAS ADMITTED TO THE FACILITY BASED ON THE CRE2 RESULTS FROM THE DIMENSION EXL SYSTEMS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION, UNNECESSARY TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CRE2 RESULTS FROM THE DIMENSION EXL SYSTEMS OR THE ADMISSION TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672346 ↗