Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA 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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (slide dispense issues) rather than a direct safety threat like a high-risk pathogen or structural failure.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products LIPA Slides, which are used to quantitatively measure Lipase (LIPA) activity in serum and plasma. The recall involves Slide Dispense cartridges used with these specific chemistry slides.
The recall is being conducted due to slide dispense issues. The affected products include LIPA Slides packaged as 300 slides per pack (catalog number 1668409) and 90 slides per pack (catalog number 8297749). These slides are compatible with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
A total of 62,039 units are affected, with 26,765 units distributed domestically in the United States and 35,274 units distributed internationally. The affected lots have expiry dates through March 22, 2015. The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of these units.
The recalled product
- Product
- VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity 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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