Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because an anti-backup platen failure may cause intermittent slide dispense issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text describes a mechanical defect causing intermittent dispense issues without reporting any injuries, illnesses, or deaths. This aligns with the 'Moderate' severity criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS chemistry Products Cl- Slides, Catalog No. 6844471, which support Urine CL- testing. These MicroSlides contain reagents in a dry, multi-layered form. The recall involves 1,365,545 units distributed domestically nationwide and to multiple foreign countries, including Australia, Belgium, Canada, China, Germany, India, Japan, Mexico, and the United Kingdom.
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 source text does not report any illnesses, injuries, or deaths associated with this defect.
Users of these products should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions or a replacement. The specific lot codes affected are listed in the official recall documentation.
The recalled product
- Product
- VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports 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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