DV/DM COV2T/CV2T CAL 11417413Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414605494), received between Apr 12, 2021 and Apr 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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.

• MalfunctionApr 12, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A DISCORDANT NONREACTIVE (NEGATIVE) DIMENSION SARS-COV-2 TOTAL ANTIBODY (CV2T) RESULT ON A REACTIVE (POSITIVE) QUALITY CONTROL SAMPLE ON A DIMENSION EXL 200 SYSTEM AFTER A CALIBRATION. THE SAME QUALITY CONTROL SAMPLE WAS REPROCESSED AFTER A SECOND RECALIBRATION OF THE ASSAY WITH THE SAME LOT OF SARS-COV-2 TOTAL ANTIBODY CALIBRATOR AND A DISCORDANT (NEGATIVE) RESULT WAS AGAIN OBTAINED. THE SAME QUALITY CONTROL SAMPLE WAS REPROCESSED ON A LATER DATE WHEN A NEW LOT OF CALIBRATOR BECAME AVAILABLE. THE QUALITY CONTROL SAMPLE RESULT WAS ACCEPTABLE (POSITIVE) AFTER THE RECALIBRATION WITH THE NEW LOT OF CALIBRATOR. THE CUSTOMER STATED THERE WAS A DELAY IN RUNNING PATIENT SAMPLES UNTIL RECALIBRATION OF THE ASSAY AND PROCESSING OF QUALITY CONTROL RESULTED WITHIN ACCEPTABLE LIMITS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DIMENSION CV2T QUALITY CONTROL RESULT OR THE PATIENT SAMPLE TESTING DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647992 ↗