Focus Diagnostics Recalls Stratify JCV DxSelect Assay Due to False Positive Risk
Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive 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 false positive results, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.
Plain-English summary
Focus Diagnostics Inc is recalling 300 units of the STRATIFY JCV DxSelect, Model No. EL1950, an in vitro diagnostic assay used to detect antibodies to JC Virus in human serum or plasma. The recall affects Lot No. 27333, which was distributed internationally to Denmark only.
The recall was initiated because a non-conforming batch was used in the manufacture of the affected kits. This manufacturing issue could lead to a potential for false positive JCV results.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting a representative.
The recalled product
- Product
- STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
- Manufacturer
- Focus Diagnostics Inc
- Hazard
- Affected units
- 300
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 (1)
- Lot No. 27333
Distribution
Distribution scope not specified by the agency.
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