Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products-HCY Reagent Lot 1529-17-2636
Ortho-Clinical Diagnostics is recalling a specific lot of VITROS Chemistry Products-HCY Reagent because it produced lower than expected 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 performance defect (lower than expected results) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 478 units of VITROS Chemistry Products-HCY Reagent, Catalog # 6802002. The product is used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
The recall is limited to Lot # 1529-17-2636, which has an expiration date of 12 June 2013. The firm is recalling this specific lot due to lower than expected results.
The affected units were distributed worldwide, including nationwide in the United States and in countries such as Colombia, India, Japan, Mexico, and others. Users of the product should check their inventory for this specific lot number and expiration date.
The recalled product
- Product
- VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
- 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)
- Lot # 1529-17-2636
- expiration date 12 June 2013
Distribution
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