Dimension® Flex® reagent cartridge TBI 10444957Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842768020544), received between Oct 17, 2018 and Apr 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 reports).

2 FDA recall records 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 13, 2020Class IITerminated

   Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

   Z-1541-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 13, 2020Class IITerminated

   Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

   Z-1540-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN (TBI) RESULTS WERE OBTAINED ON THREE (3) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED USING ANOTHER REAGENT LOT ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPROCESSED RESULTS RECOVERED HIGHER THAN THE ERRONEOUSLY DEPRESSED RESULTS AND WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN (TBI) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863569 ↗
• MalfunctionMay 25, 2022Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPROCESSED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS ISSUED FOR SOME SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED TBI RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14500038 ↗
• MalfunctionFeb 7, 2019Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED TOTAL BILIRUBIN (TBI) RESULT WAS OBTAINED ON A NEONATE PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND PROCESSED AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TBI RESULT. NO CORRECTED REPORTED WAS ISSUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317404 ↗
• MalfunctionOct 17, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED AND DISCORDANT FALSELY ELEVATED TOTAL BILIRUBIN (TBI) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED THE SAME DAY AND A CORRECT RESULT WAS OBTAINED. THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED AND FALSELY ELEVATED TBI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975101 ↗