Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum 0066905Recalls & reported problems
Immucor, Inc. · Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays. · Class 1
Data updated Oct 18, 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 10888234001577), received between Jul 30, 2020 and Jul 30, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive 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
Device problems
- False Positive Result1
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.
MalfunctionJul 30, 2020False Positive Result; False Positive Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENT INDICATED THAT ONE (1) PATIENT SAMPLE TEST HAD AN RH MISTYPE RESULTING IN AN ANTI-D + TYPING VERSUS A KNOWN NEGATIVE ANTI-D PHENOTYPE; USING THE ANTI-D SERIES 5 REAGENT THAT WAS APPLIED TO A CMT PLATE (COATED MICRO-TYPING PLATE). SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10346448 ↗
Other Supplies, Blood-Bank devices
- GPS® III Platelet Concentration System 800-1003ABiomet Biologics, LLC · SUPPLIES, BLOOD-BANK2 reports
- Capture-P Indicator Red Cells 0066240Immucor, Inc. · Supplies, Blood-Bank2 reports
- Capture-P 0066251Immucor, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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