Capture-P 0066251Recalls & reported problems
Immucor, Inc. · Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10888234001300), received between Mar 9, 2017 and Mar 9, 2017 — 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 16, 2026.
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2017False Negative Result
ON (B)(6) 2017, IT WAS DETERMINED THAT TESTING AT A CUSTOMER SITE ON (B)(6) 2017 YIELDED AN UNEXPECTEDLY COMPATIBLE PAIR OF CAPTURE-P RESULT OUTCOMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6392875 ↗
Other Supplies, Blood-Bank devices
- Capture-P Indicator Red Cells 0066240Immucor, Inc. · Supplies, Blood-Bank2 reports
- GPS® III Platelet Concentration System 800-1003ABiomet Biologics, LLC · SUPPLIES, BLOOD-BANK2 reports
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum 0066905Immucor, Inc. · Supplies, Blood-Bank1 report
- Capture-P 0066246Immucor, Inc. · Supplies, Blood-Bank1 report
- TERUMO SAMPLING SITE COUPLER TC*MP1Terumo Corporation · Supplies, Blood-Bank1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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