Ortho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias
Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides, Lot 3920-0080-8403, because they may produce biased carbamazepine results.
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. The hazard is a potential for biased diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRBM Slides, Reference 889 2382, Lot 3920-0080-8403. The recall involves 20 units of the product, which is used for in vitro diagnostic testing to measure carbamazepine concentration in serum and plasma.
The firm identified a potential for biased carbamazepine results to be generated when using the affected slides. The product was distributed in the United States to the states of Indiana, Maryland, and Tennessee.
Consumers and healthcare facilities should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS…
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 20
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)
- Lot 3920-0080-8403
- expiry date 15-JUNE-2014
Distribution
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