Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products COCM Reagent
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products COCM Reagent because of inaccurate quality control results. The recall affects 3,342 units distributed worldwide.
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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is limited to inaccurate quality control results, which fits the criteria for a moderate severity recall involving potential performance issues without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 3,342 units of VITROS Chemistry Products COCM Reagent. The recall was initiated due to inaccurate quality control results. The affected product is identified by Product Code 6801995 and includes three specific lot numbers with expiration dates ranging from November 2013 to April 2014.
The recalled product was distributed worldwide, including nationwide in the United States and in specific countries such as Colombia, India, Japan, Mexico, and several European nations. The source text does not specify the exact number of units distributed in each region.
Consumers and healthcare facilities should stop using the affected VITROS Chemistry Products COCM Reagent and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products COCM Reagent
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 3,342
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 (5)
- Product Code: 6801995
- Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013
- 2) 1525-10-2091 Exp Date: 1 March 2014
- 3) 1525-10-3062
- Exp Date: 1 April 2014
Distribution
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