IH-Internal QC 814172100Recalls & reported problems
Bio-Rad Medical Diagnostics GmbH · For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal) · Class 2
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 07611969952342), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2020Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THEY RAN IH-INTERNAL QC SAMPLE 4 FOR THE WEAK D POSITIVE CONTROL, BUT THE TECH FORGOT TO ADD ANTI-D BLEND THUS GETTING A NEGATIVE RESULT. EVEN THOUGH THE RESULT WAS NEGATIVE AND THE IH-READER 24 INTERPRETED THE RESULT AS "D NEGATIVE," THE SYSTEM MARKED THE QC AS BEING PASSED. THE CUSTOMER HAD TO CHANGE THE "RH D WEAK" TO "RH D POSITIVE" FOR THE SYSTEM TO INTERPRET THE WEAK D QC CORRECTLY. THE QC SETTINGS ON THE PROVIDED PRINT SCREENS WERE CORRECT. PRINT SCREENS PICTURES AND SUPPORT BACKUP DO NOT ALLOW TO CONFIRM THESE SETTINGS AS BEING THE ONE CONFIGURED NOW OF QC SAMPLE PROCESSING DUE TO NO DATE AND TIME ON THE PRINT SCREEN PICTURES. FURTHERMORE, THE SUPPORT BACKUP (PROVIDED FROM OCTOBER 30TH) WAS TAKEN MORE THAN 7 DAYS AFTER THE ISSUE HAS OCCURRED (SEPTEMBER 15TH). THEREFORE, ONLY TRUNCATED LOG DATA WERE AVAILABLE. WE COULD CONFIRM THAT THE RHD WEAK INTERPRETATION IS NOT PROPERLY COMPARED TO THE RHD RESULT INTERPRETATION WHEN NO "REQUIRED REACTIONS" ARE SET WHEN USING THE CURRENT VALIDATED IH-COM VERSION V5.0.9 OR V5.0.10. HOWEVER, THIS ISSUE IS BEING SOLVED WITHIN THE INTRODUCTION OF THE UPCOMING IH-COM VERSION. THE ADVICE FOR THE USER FOR A WORKAROUND
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10710000 ↗
Other Kit, Quality Control For Blood Banking Reagents devices
- Capture-R Ready Indicator Red Cells 0006428Immucor, Inc. · Kit, Quality Control For Blood Banking Reagents52 reports
- Capture-R Ready Indicator Red Cells 0006427Immucor, Inc. · Kit, Quality Control For Blood Banking Reagents7 reports
- ALBAcyte C3 Coated Red Blood Cells Z482UAlba Bioscience Limited · Kit, Quality Control For Blood Banking Reagents2 reports
- VIROTROL 00101FBio-Rad Laboratories, Inc. · KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS1 report
- VIROTROL 00100ABio-Rad Laboratories, Inc. · KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS1 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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