VITROS 1009406Recalls & reported problems
Ortho Clinical Diagnostics · VITROS Immunodiagnostic Products RE Controls · Class 1
- 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 10758750008322), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem1
Patient problems
- Foreign Body Sensation in Eye1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2024Use of Device Problem; Use of Device Problem
THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) WAS CONTACTED TO REPORT A VITROS OPERATOR EXPERIENCED LEFT EYE PAIN POTENTIALLY CAUSED BY GLASS DUST THAT MAY HAVE ENTERED HIS LEFT EYE, PRODUCED BY A SHATTERED GLASS BOTTLE OF VITROS REPRODUCTIVE ENDOCRINE (RE) CONTROLS. THE OPERATOR IMMEDIATELY RINSED HIS EYE WITH WATER AND THEN SOUGHT MEDICAL TREATMENT. THE EYE DOCTOR WAS ABLE TO VERIFY THAT THE EYE, THOUGH INFLAMED, DID NOT CONTAIN ANY FOREIGN MATERIAL AND DID NOT LOOKED DAMAGED FROM SCRATCHING. PER MEDICAL CONSULTATION FROM MEDICAL SAFETY OFFICER (B)(6) DATED (B)(6) 2024: PER THE SDS, THE RE CONTROL CONTAINS HUMAN PLASMA, HUMAN CORD SERUM/PLASMA, AND KATHON (A CHEMICAL MIXTURE). DUE TO THE PRESENCE OF HUMAN BLOOD AND BLOOD PRODUCTS, THERE EXISTS THE RISK OF TRANSMISSION OF BLOOD-BORNE PATHOGENS UPON EXPOSURE TO THE BODY MUCOSA. DONORS AND DONATION BLOOD FOR ORTHO REAGENTS TESTED NEGATIVE PER CURRENT FDA-REQUIRED TESTS; THEREFORE, THE CHANCE OF BEING TRANSMITTED WITH THE COMMON BLOOD-BORNE PATHOGENS IS LOW. HOWEVER, NO TEST CAN GUARANTEE 100% DETECTION. SO, FOR PRECAUTION, THIS CASE IS CLASSIFIED AS SERIOUS INJURY. THE REAGENT IS ALSO LISTED AS AN EYE IRRITA
Patient problems: Foreign Body Sensation in Eye
MAUDE report 20080639 ↗
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- LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 3 (LIQ CHEM ASY PREMIUM 3) LAE4217Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-303Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- IMMUNOASSAY PREMIUM - TRI-LEVEL (IA PREMIUM 1, 2 AND 3) IA2633Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3) IA2640Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-202Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.