Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because slide dispense cartridges may cause dispensing problems.
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 does not report any illnesses, injuries, or deaths, indicating a moderate risk of harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides, catalog number 8097990, packaged as 90 slides per pack. The recall is due to slide dispense issues associated with the Slide Dispense cartridges used with these products.
The affected slides are used to quantitatively measure C-reactive protein (CRP) concentration in serum and plasma on VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall involves 86,522 units, distributed nationwide in the United States and internationally to multiple countries. Multiple lots are affected, with expiry dates through March 22, 2015.
Healthcare facilities and laboratories should stop using the affected VITROS CRP Slides and contact Ortho-Clinical Diagnostics for further instructions on returning or disposing of the product.
The recalled product
- Product
- VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
- 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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