Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.
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 or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Ca Slides packaged as 300 slides per pack, catalog number 1450261. These slides are used to quantitatively measure calcium concentration in serum, plasma, and urine on specific VITROS Chemistry Systems. The recall is due to slide dispense issues associated with the Slide Dispense cartridges used with the product.
The recall affects 231,112 units, with 133,173 units distributed domestically in the United States and 97,939 units distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and various countries in the Americas, Europe, and Asia.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine 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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