Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results
A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic device with a documented software defect that may cause erroneous patient test results. No hospitalizations, injuries, or illnesses have been reported, placing it in the category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
The VITROS 3600 Immunodiagnostic System, manufactured by Ortho-Clinical Diagnostics, Inc., is a laboratory diagnostic device used to perform immunological tests. The recall affects systems running VITROS Software Version 3.8.1.
A software defect in this version prevents quality control (QC) baseline statistics from updating as expected when user-initiated changes are made. This defect may cause the system to report erroneous patient test results without properly applying updated quality control parameters.
The recall involves 1 unit distributed in the United States (in Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin, and West Virginia) and 36 units distributed internationally (in Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium). Healthcare facilities using this software version should contact Ortho-Clinical Diagnostics, Inc. for guidance on software updates or remediation.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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