Capture-P Indicator Red Cells 0066240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234001256), received between Nov 1, 2016 and Apr 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

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

Recent adverse event reports

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

• MalfunctionApr 30, 2020False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING CAPTURE-P INDICATOR CELLS REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED NEGATIVES WITH CAPTURE P READY SCREEN DUE TO A DEFECTIVE DROPPER DISPENSING TOO MUCH REAGENT. THE ORIGINAL TESTING WAS PERFORMED USING THE DROPPER INSIDE OF THE INDICATOR CELL VIAL AND 1 DROP WAS USED. ON THE REPEAT TESTING THE CUSTOMER USED A CALIBRATED PIPETTOR WITH EXACTLY 50 UL AND A POSITIVE RESULT WAS RECEIVED. THE ERROR WAS CAUSED BY THE CUSTOMER'S INCORRECT TESTING METHODS. THE RESULT REPRESENTED A FALSE NEGATIVE BASED ON PRIOR PATIENT HISTORY. SUBSEQUENT TESTING OF THE RETENTION LOT SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO OTHER SPECIFIC CAUSES WERE DETERMINED AS A CAUSE OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10016365 ↗
• MalfunctionNov 1, 2016False Negative Result

  ON 04OCT2016, A CUSTOMER REPORTED UNEXPECTED PLATELET CROSSMATCH REACTIONS WITH CAPTURE-P READY INDICATOR CELLS LOT 226342. ON (B)(6) 2016, 8 DONORS SAMPLES WERE TESTED WITH ONE PATIENT SAMPLE USING CAPTURE-P LOT P171 AND CAPTURE P INDICATOR CELLS LOT 226342, AND 4 OF THE 8 DONORS RESULTED COMPATIBLE. ON (B)(6) 2016, THEY TESTED THE SAME PATIENT SAMPLE WITH 8 DIFFERENT SAMPLES FROM (B)(6) 2016 WITH CAPTURE-P LOT P171 AND CAPTURE P INDICATOR CELLS LOT 226343 AND ALL 8 DONORS WERE INCOMPATIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6069902 ↗