BioPlex® 2200 6633435Recalls & reported problems
Bio-Rad Laboratories, Inc. · BioPlex 2200, HIV Ag-Ab Control Set · Class 2
All models of BioPlex 2200 (8)
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 03610520506493), received between Dec 13, 2016 and Dec 13, 2016.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Human Factors Issue1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Dec 13, 2016Human Factors Issue; Human Factors Issue
THE CHEMISTRY SUPERVISOR ACCIDENTLY DROPPED ONE OF THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIALS AND THE LIQUID SPLASHED TOWARDS HER EYES. THE OPERATOR WAS NOT WEARING ANY SORT OF PERSONAL PROTECTIVE EQUIPMENT (PPE), HOWEVER SHE WAS WEARING GLASSES. SOME OF THE LIQUID FROM THE QC VIAL DID SPLASH INTO ONE OF HER EYES. THE CHEMISTRY SUPERVISOR IMMEDIATELY SOUGHT CARE FROM ONE OF THE HOSPITAL NURSES FOR THE SPLASHED LIQUID IN HER EYE. ACCORDING TO THE NURSE, NO MEDICAL INTERVENTION WAS NECESSARY AT THAT TIME, SO NO INCIDENT REPORT WAS FILED BY THE LAB BECAUSE THEY DID NOT FEEL IT WAS NECESSARY DUE TO THE MINOR ACCIDENT. BIO-RAD LABORATORIES IS REPORTING THIS ADVERSE EVENT TO ENSURE THAT THE SPLASH HAS NO LONG TERM DAMAGE TO THE AFFECTED PERSON BECAUSE OF THE EXPOSURE TO THE BIOLOGICAL MATERIALS IN THE BIOPLEX 2200 AG-AB QUALITY CONTROL (QC) VIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6169746 ↗
Other Test, Hiv Detection devices
- Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection409 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection238 reports
- Elecsys HIV Duo 08836973190Roche Diagnostics GmbH · Test, HIV detection105 reports
- ARCHITECT 2P36-01Abbott GmbH · Test, hiv detection1 recall0 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Alere Scarborough, Inc. · Test, Hiv Detection27 reports
- cobas® HIV-1 09040803190Roche Molecular Systems, Inc. · Test, HIV detection27 reports
- VITROS 6842781Ortho Clinical Diagnostics · Test, hiv detection16 reports
- RealTime 6L18-90Abbott Molecular Inc. · Test, hiv detection12 reports
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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