Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because extension springs may be out of specification, potentially causing imprecise 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 voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. (OCD) is recalling VITROS 4600 Chemistry Systems (Product Code 6802445) 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, 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 chemistry analyte results. OCD's evaluation determined that the probability of an out-of-specification extension spring alone adversely affecting results is unlikely.
The recall affects 58 units in the USA and 103 units in foreign countries, including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela. Affected units have serial numbers ranging from 46000108 through 46000217. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. 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 46000108 through 46000217
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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