Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.
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 explicitly states that the probability of adverse effects is unlikely and no injuries or illnesses are reported, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. (OCD) is recalling VITROS 5600 Integrated Systems (Product Code 6802413) due to a manufacturing defect in the extension springs. These springs are part of the slide alignment guide assembly and are intended to ensure proper positioning of MicroSlides within the incubator.
During an internal evaluation at its manufacturing facility, OCD discovered that some extension springs had insufficient force. If the springs do not provide sufficient force, MicroSlides may not be properly positioned, which has the potential to cause imprecise results in the measurement of chemistry analytes. OCD's evaluation determined that the probability of an out-of-specification extension spring alone adversely affecting results is unlikely.
The recall affects 775 units in the USA (including Puerto Rico) and 800 units in foreign countries, including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela. The affected serial numbers range from 56000118 through 56001583. Users should contact Ortho-Clinical Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 56000118 through 56001583
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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