Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.
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 involves a mechanical malfunction (dispense issues) rather than a direct health risk like contamination or injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS chemistry Products Cl- Slides, Catalog No. 8445207. These MicroSlides contain reagents in a dry, multi-layered form and are used for chemistry testing. The recall involves 1,365,545 total units.
The recall was initiated because users may experience intermittent slide dispense issues with some cartridges. This is attributed to the anti-backup platen failing to advance inside the cartridge. The product was distributed domestically nationwide and in foreign markets including Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom.
Users of these products should check their inventory for the affected catalog number and contact Ortho-Clinical Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 1,365,545
Distribution
Distributed nationwide across the United States.
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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