Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 55 units of the VITROS 5600 Integrated System, specifically software versions 3.3.2 and below. The recall is due to a luminometer malfunction that may cause the system to be unable to process MicroWell assays. The affected product is used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest using VITROS Immunodiagnostic Products Reagents.
The recall covers units with serial numbers 56003270 and above and UDI 10758750002740. The product was distributed worldwide, including the United States and countries such as Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.
Healthcare facilities and users should stop using the affected software and contact Ortho-Clinical Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 55
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 (1)
- Serial Numbers: 56003270 & above UDI: 10758750002740
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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