Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.
What this means for you
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (erroneous diagnostic results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Chemistry System, Catalog Number 6802783, with Software Version 3.2 and below. The recall affects serial numbers J36000012 through 36000879. The device is an in vitro diagnostic (IVD) used for the quantitative, semi-quantitative, and qualitative measurement of various clinical analytes.
The recall is due to a software anomaly that may allow the system to sample and process assays while fluids and reagent temperatures are outside the required range for optimal processing. When this intermittent issue occurs, the system continues to operate and process results without notifying the user, which may result in erroneous test outcomes.
The recall covers 200 units distributed domestically in the United States and Puerto Rico, and 554 units distributed internationally to countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the software update or replacement.
The recalled product
- Product
- VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Version 3.2 and below
- Serial Numbers J36000012 - 36000879
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ortho-Clinical Diagnostics 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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