Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Li Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides due to 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a mechanical 'slide dispense issue' rather than a direct biological hazard or reported injury, fitting the Moderate category for functional defects without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides, which are used to quantitatively measure lithium concentration in serum and plasma. The recall involves Slide Dispense cartridges used with these slides due to slide dispense issues.
The affected products include VITROS Li Slides packaged as 300 slides per pack (catalog number 8318925) and 90 slides per pack (catalog number 1632660). These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Multiple lots are affected, with expiry dates through March 22, 2015.
The recall covers 62,039 units, including 5,974 units distributed domestically in the United States and 4,702 units distributed internationally. The products were distributed nationwide in the US, including Puerto Rico, and to various countries in South America, Asia, Europe, and North America. Users should stop using the affected Slide Dispense cartridges and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
- 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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