VIROTROL 00101FRecalls & reported problems
Bio-Rad Laboratories, Inc. · VIROTROL I (An unassayed (human) serological control.) · Class 2
Data updated Oct 16, 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 00847661005544), received between May 18, 2023 and May 18, 2023 — classified as 1 malfunction.
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
Device problems
- No Apparent Adverse Event1
Patient problems
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2023No Apparent Adverse Event; No Apparent Adverse Event
AT 23:55 ON (B)(6) 2023, A TRAVELING TECHNICIAN SPLASHED VIROTROL I CLASS F, LOT 116820 ON THE RIGHT EYE WHEN THE PRODUCT TUBE WAS OPENED. THE EVENT OCCURRED AT (B)(6) GENERAL HOSPITAL IN (B)(6) VA, USA . THE TECHNICIAN RINSED EYES WITH EYE WASH FOR 15 MINUTES. THE TECHNICIAN HAS THE PRODUCT INSERT ON HAND. BIO-RAD TECHNICAL SERVICE PROVIDED THE PRODUCT SAFETY DATA SHEET AND CERTIFICATE OF ANALYSIS FOR THE VIROTROL I CLASS F, LOT 116820. ON (B)(6) 2023, THE TECHNICIAN NOTIFIED BIO-RAD THAT BASELINE TESTING FOR INFECTIOUS MARKERS WAS PERFORMED AT COMPANY'S OCCUPATIONAL HEALTH DEPARTMENT.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 16958732 ↗
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
- IH-Internal QC 814172100Bio-Rad Medical Diagnostics GmbH · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page