Capture-R Select 0006446Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888234000655), received between Nov 14, 2016 and Jul 30, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TWO (2) PATIENT SAMPLE TESTS USING THE CAPTURE-R SELECT REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT WITH A DAT ASSAY AND AN UNEXPECTED COMPATIBLE CROSSMATCH RESULT. 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 10347309 ↗
• MalfunctionOct 29, 2019False Positive Result; False Positive Result

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. A REVIEW OF THE EVENT INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE CAPTURE-R SELECT REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED A POSITIVE CROSSMATCH RESULT. THE RESULT WAS A FALSE POSITIVE GIVEN CUSTOMER TESTING USING LISS/TUBE AND PEG/TUBE METHODS SHOWED INCOMPATIBILITY. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252169 ↗
• MalfunctionApr 18, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019 A CUSTOMER RECEIVED UNEXPECTED NEGATIVE WITH IGG CROSSMATCH USING CAPTURE-R SELECT ON THE ECHO INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8528594 ↗
• MalfunctionJun 26, 2018False Negative Result; False Negative Result

  ON 31MAY2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE COMPATIBLE CROSSMATCH WHEN USING CAPTURE-R SELECT STRIPS ON TWO (2) GALILEO ECHO INSTRUMENTS, WHEN TESTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638978 ↗
• MalfunctionMay 22, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE COMPATIBLE CROSSMATCH WHEN USING CAPTURE-R SELECT STRIPS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534667 ↗
• MalfunctionNov 13, 2017False Negative Result

  ON (B)(6) 2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE COMPATIBLE CROSSMATCH WHEN USING CAPTURE-R SELECT STRIPS ON A GALILEO NEO INSTRUMENT, UNDER A VALIDATION CHALLENGE SCENARIO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7026305 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected

  ON 19MAY2017, A CUSTOMER SITE REPORTED AN UNEXPECTED WEAK D POSITIVE OUTCOME WHEN USING CAPTURE-R SELECT ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017. THE RECORD WAS SUBSEQUENTLY DEEMED TO BE REPORTABLE TO FDA ON 24MAY2017.

  Patient problems: No Code Available

  MAUDE report 6658012 ↗
• MalfunctionNov 14, 2016False Negative Result

  ON (B)(6) 2016, AN ON-SITE IMMUCOR EMPLOYEE, AT A CUSTOMER SITE, REPORTED SOME UNEXPECTED NEGATIVE COMPATIBLE CROSSMATCH RESULTS WHEN USING CAPTURE-R SELECT ON A GALILEO ECHO INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6100075 ↗