VIROTROL 00100ARecalls & reported problems
Bio-Rad Laboratories, Inc. · VIROTROL I (An unassayed (human) serological control.) · Class 2
Data updated Oct 13, 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 00847661004240), received between Feb 6, 2018 and Feb 6, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Human Factors Issue” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Human Factors Issue1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2018Human Factors Issue; Human Factors Issue
ON (B)(6) 2018 BIO-RAD QSD TECHNICAL SUPPORT RECEIVED A REPORT FROM (B)(6) REPORTING THAT A LABORATORY INDIVIDUAL HAD SPLASHED VIROTROL I CONTROL INTO HER EYE. THE INDIVIDUAL CLEANED HER EYES BY SPLASHING WATER. SHE ALSO SAW A DOCTOR IN THE HOSPITAL AND WAS TESTED FOR (B)(6) ANTIBODY. THE INCIDENT OCCURRED IN THE HOSPITAL LAB.
Patient problems: Chemical Exposure
MAUDE report 7246263 ↗
Other KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS devices
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- 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
- IH-Internal QC 814172100Bio-Rad Medical Diagnostics GmbH · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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