Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product ALC Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides due to slide dispense issues affecting the cartridges used with the product.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text cites a mechanical 'slide dispense issue' rather than a direct biological hazard or reported injury, aligning with a moderate severity rating for a functional defect in a medical device.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides, catalog number 8046872. These slides are used to quantitatively measure ethanol (ALC) concentration in serum and plasma on various VITROS Chemistry Systems.
The recall is being conducted because of slide dispense issues associated with the Slide Dispense cartridges used with the product. The affected units have expiry dates through March 22, 2015.
A total of 28,501 units were distributed, with 20,321 units distributed domestically in the United States and 8,180 units distributed internationally. The product was distributed nationwide in the US, including Puerto Rico, and to several countries in South America, Asia, Europe, and North America. Users of these products should contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- 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 (2)
- Multiple lots affected
- with expiry dates through 22-Mar-2015
Distribution
Part of a larger recall action
This product is one of 37 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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