Ortho VITROS 5600 System Recalled for Software Calibration Error
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a software anomaly that may lead to improper calibration identification without reported injuries or illnesses.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System, Catalog Number 6802413, due to a software anomaly. The firm identified that software versions 3.1 and below may not properly identify an expired calibration.
The recall affects 1,830 units distributed worldwide, including 877 in the United States and 953 in foreign countries. The affected units have serial numbers ranging from J56000110 to J56002044.
Healthcare facilities should contact Ortho-Clinical Diagnostics for instructions on how to address the software issue.
The recalled product
- Product
- VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemist
- 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 (3)
- Software Version 3.1 & Below
- Serial Numbers J56000110 - J56002044 (the serial numbers are sequential
- J Numbers are analogous to serial numbers)
Distribution
Part of a larger recall action
This product is one of 3 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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