VITROS 8262487Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS 7% BSA · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750004652), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
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.
InjuryApr 17, 2025Device Handling Problem; Device Handling Problem
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT 7% BOVINE SERUM ALBUMIN (BSA) FLUID SPLASHED INTO THE EYE OF AN OPERATOR WHILE OPENING THE FLUID VIAL WHEN PERFORMING DAILY MAINTENANCE ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE OPERATOR WAS SEEN BY AN EMERGENCY ROOM PROVIDER ON (B)(6) 2025, WHO STATED THAT THE OPERATORS EYE APPEARED UNHARMED. THE OPERATOR DID NOT FEEL AND CURRENTLY DOES NOT FEEL ANY ITCHING, BURNING OR PAIN IN THE EYE SINCE THE EVENT. A MEDICAL CONSULTATION WAS OBTAINED FROM AN ORTHO MEDICAL SAFETY OFFICER ON (B)(6) 2025: AN OPERATOR HAD A SPLASH OF 7% BSA (BOVINE SERUM ALBUMIN) SOLUTION INTO THEIR LEFT EYE WHILE TRYING TO REMOVE THE RUBBER CAP ON THE BOTTLE. THE LEFT EYE WAS WASHED WITH EYE SALINE AND HAD UNSPECIFIED TREATMENT AT THE EMERGENCY ROOM (ER). BASED ON THE AVAILABLE INFORMATION, THE RISK OF SERIOUS EYE INJURY ON THE OPERATOR IS UNLIKELY. HOWEVER, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY DUE TO THE UNCERTAINTY OF INFECTION RISK. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 21857708 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.