Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased 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 source text does not report any hospitalizations, injuries, or deaths, and the hazard is a measurement bias rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 5,850 units of VITROS Chemistry Products dLDL Reagent GENs 26 and 27. This in vitro diagnostic is used to quantitatively measure LDL Cholesterol (LDLC). The recall is due to the product producing negatively biased results.
The affected lot numbers are 1517-26-6396, 1517-26-6582, 1517-26-6639, and 1517-27-6808. The distribution was nationwide and included several foreign countries, including Australia, Belgium, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, and the United Kingdom.
This is a Class II recall. No specific instructions for consumers are provided in the source text, but the product is intended for in vitro diagnostic use.
The recalled product
- Product
- VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 5,850
Distribution
Distributed nationwide across the United States.
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