Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software
Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is a software anomaly affecting reagent stability rather than a direct physical danger like fire or choking.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 728 units of the VITROS 4600 Chemistry System, Version 3.3.1 and below. The product is used for the in vitro quantitative measurement of various analytes in biological fluids such as serum, plasma, urine, and cerebrospinal fluid. The recall covers units with Product Code 6802445, UDI 10758750012343, and serial numbers ranging from J46000108 to J46001132.
The recall was initiated because a software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. This issue could potentially affect the accuracy of test results. The affected units were distributed nationwide in the United States.
Healthcare facilities and users of the VITROS 4600 Chemistry System should check their inventory for the specific serial numbers and product codes listed above. Users should contact Ortho-Clinical Diagnostics for instructions on how to resolve the software issue or replace the affected units.
The recalled product
- Product
- VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 728
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)
- Product Code: 6802445 UDI: 10758750012343 Serial Numbers: J46000108-J46001132
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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