Ortho-Clinical Diagnostics Recalls VITROS K+ Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause 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, but the hazard is 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 K+ Slides, Catalog No. 8157596. These are MicroSlides that contain reagents in a dry, multi-layered form. The recall involves 1,365,545 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 to numerous foreign countries 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 should check their inventory for the specific catalog number and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- VITROS chemistry Products K+ Slides, Catalog No. 8157596. 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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