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Capture-P 0066246Recalls & reported problems

Immucor, Inc. · Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234001270), received between Sep 21, 2016 and Sep 21, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Or Inadequate 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionSep 21, 2016Incorrect Or Inadequate Test Results

    ON (B)(6) 2016, A CUSTOMER SITE REPORTED TEN (10) UNEXPECTED NEGATIVE PLATELET CROSSMATCH TESTS WHEN TESTED AGAINST ONE SINGLE BLOOD SAMPLE, WHEN USING CAPTURE-P.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5966769 ↗

Other Supplies, Blood-Bank devices

All Supplies, Blood-Bank devices →

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