Dimension® CHEM I CAL 10716280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414948492), received between Sep 8, 2017 and Jun 28, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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.

• MalfunctionJun 28, 2019Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745043 ↗
• MalfunctionJun 28, 2019Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745035 ↗
• MalfunctionSep 8, 2017Low Test Results; Low Test Results

  DISCORDANT FALSELY LOW GLUCOSE (GLU) RESULTS WERE OBTAINED ON THE DIMENSION XPAND PLUS. BIASED LOW RESULTS WERE OBTAINED WHILE THE CUSTOMER ACCEPTED A BAD CALIBRATION DUE TO UNDER-RECONSTITUTION OF THE CALIBRATOR. ONE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN FOR PATIENT SAMPLE IDENTIFICATION (B)(6) AND NOT QUESTIONED. NO OTHER PATIENT RESULTS WERE REPORTED AND A CORRECTED REPORT WAS ISSUED FOR THE INITIAL RESULT REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW GLUCOSE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851958 ↗