Capture-R Ready Indicator Red Cells 0006427Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888234000594), received between Nov 8, 2016 and Mar 2, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, A CUSTOMER REPORTED A SUSPECTED DELAYED TRANSFUSION REACTION WITH A PATIENT WHOSE SAMPLES WERE INITIALLY NEGATIVE BY SCREEN AND ID, BUT ANTI-S WAS IDENTIFIED WITH LATER SAMPLE.

  Patient problems: Fever

  MAUDE report 13657144 ↗
• MalfunctionJan 30, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING CAPTURE-R READY INDICATOR CELLS REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED NEGATIVE RESULT FOR A SPECIFIC ANTIBODY. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. THE MALFUNCTION DID NOT SHOW A POSITIVE RESULT AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9650016 ↗
• MalfunctionMay 20, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT ON A GALLIEO ECHO V2.0 INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624725 ↗
• MalfunctionApr 19, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533251 ↗
• MalfunctionNov 22, 2017False Negative Result

  ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2017. A SUBSEQUENT BLOOD SAMPLE ((B)(6)) FOR THE SAME PATIENT ALSO YIELDED AN UNEXPECTED NEGATIVE SCREEN OUTCOME WHEN TESTED ON (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054455 ↗
• MalfunctionJun 27, 2017False Negative Result

  ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671370 ↗
• MalfunctionNov 8, 2016False Negative Result

  ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6086806 ↗