Ortho-Clinical VITROS 3600 Immunoassay System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay 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, and the hazard is a functional malfunction (inability to process assays) rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunoassay System software, specifically versions 3.3.2 and below. The recall affects 267 units distributed worldwide, including the United States and various international markets. The product is used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes.
The recall was initiated because a luminometer malfunction may cause the system to be unable to process MicroWell assays. This defect could impact the ability to perform specific tests on the affected devices.
Healthcare facilities and users of the VITROS 3600 Immunoassay System should contact Ortho-Clinical Diagnostics for further instructions on how to address the software malfunction and ensure proper device operation.
The recalled product
- Product
- VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 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
- 267
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: 36001160 & above UDI: 10758750002979)
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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