Ortho-Clinical Diagnostics Recalls VITROS CRBM Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides because of slide dispense issues. The slides are used to measure carbamazepine levels in serum and plasma.
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. The hazard involves a mechanical dispense issue rather than a direct biological or chemical contamination, and no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack (catalog number 8892382). The recall is due to slide dispense issues with the Slide Dispense cartridges used with these products.
These slides are used to quantitatively measure carbamazepine (CRBM) concentration in serum and plasma. They are compatible with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The recall affects 12,484 units, with 9,040 units distributed domestically in the United States and 3,444 units distributed internationally. Multiple lots are affected, with expiry dates through March 22, 2015. Distribution was worldwide, including the United States (nationwide), Puerto Rico, and various international locations.
The recalled product
- Product
- VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
- 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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