Dimension® EXL™ LOCI® Module Flex® reagent cartridge TSHL 10464524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768022081), received between Jun 11, 2026 and Jun 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSHL) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULTS AND WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS SINCE THEY MATCHED THE PATIENT¿S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TSHL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469430 ↗