Dimension® Flex® reagent cartridge MALB 10444977Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768005312), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionMay 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED THAT THEY WERE INFORMED OF A PROFICIENCY SURVEY FAILURE FOR MICROALBUMIN (MALB) ON A DIMENSION® EXL¿ 200 SYSTEM. THE CUSTOMER REPORTED A RESULT THAT WAS LOW OUT OF THE EXPECTED RANGE FOR THE SAMPLE. THE CUSTOMER STATED THAT THEY BELIEVE SOME PATIENT RESULTS COULD HAVE BEEN RELEASED WITH LOWER VALUES. THE CUSTOMER HAS SENT LETTERS TO APPROXIMATELY 21 PATIENTS REQUESTING A NEW SAMPLE BE DRAWN AND TESTED. THE CUSTOMER STATED THAT PATIENTS COULD HAVE RECEIVED DISCORDANT LOW RESULTS. THE CUSTOMER HAS NOT PROVIDED ANY PATIENT TESTING DATA. THE CUSTOMER HAS ALSO NOTIFIED THE PHYSICIANS OF THE POTENTIALLY IMPACTED PATIENTS. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DISCORDANT MALB RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903213 ↗