Ortho VITROS 3600 Immunodiagnostic System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.
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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System, which is used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes. The recall involves 142 domestic units and 536 foreign units distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall was initiated because internal testing identified an anomaly in VITROS System Software Version 3.0 and below. Under very specific conditions, the software may associate incorrect patient demographics with a sample identification (ID) number. The affected units have serial numbers ranging from J36000101 to J36000806.
Healthcare facilities and users of the VITROS 3600 system should contact Ortho-Clinical Diagnostics for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5
- Manufacturer
- Ortho-Clinical Diagnostics
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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