Skip to content

CMT Plates 0089000Recalls & reported problems

Immucor, Inc. · CMT Plates are intended to be used in hemagglutination assays on Immucor automated instruments. CMT Plates are composed of micro-wells coated to block the nonspecific adsorption of red blood cells or serum proteins to the plastic wells. CMT Plates are supplied in a plate format. Each plate has twelve strips on a support frame and each strip has eight micro-wells. Strips can be used individually or in multiples. This product configuration is forty (40) microplates. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234001591), received between Jun 9, 2017 and Apr 25, 2019 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • False Negative Result1
  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2019False Negative Result; False Negative Result

    ON (B)(6) 2019 A CUSTOMER REPORTED RECEIVING AND UNEXPECTED NEGATIVE WHEN ANTIGEN TYPING A KNOWN POSITIVE SAMPLE ON THE GALILEO ECHO USING CMT PLATES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8552615 ↗
  • MalfunctionJun 9, 2017Incorrect Or Inadequate Test Results

    ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED ABO BLOOD TYPE ANTIGEN MISTYPE, WHEN TESTED ON A GALILEO ECHO, WHEN USING CMT PLATES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6630318 ↗

Other System, Test, Automated Blood Grouping And Antibody devices

All System, Test, Automated Blood Grouping And Antibody devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.