Dimension® Flex® reagent cartridge CA 10444949Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768014123), received between Nov 17, 2021 and Jan 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ABNORMAL ASSAY FLAGGED CALCIUM (CA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE FLAGGED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED BETWEEN AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND ATELLICA ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ABNORMAL ASSAY FLAGGED CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111798 ↗
• MalfunctionJan 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ABNORMAL ASSAY FLAGGED CALCIUM (CA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE FLAGGED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED BETWEEN AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND ATELLICA ANALYZER. 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 THE ABNORMAL ASSAY FLAGGED CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111748 ↗
• MalfunctionNov 17, 2021Low Test Results; Low Test Results

  A FALSELY DEPRESSED DISCORDANT CALCIUM (CA) PATIENT SAMPLE RESULT WAS OBTAINED ON THE DIMENSION® EXL¿ 200 SYSTEM. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLE WAS REPROCESSED USING A DIFFERENT REAGENT LOT AND A HIGHER RESULT WAS OBTAINED. THE CUSTOMER DID NOT ISSUE A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832467 ↗