Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STRATIFY JCV DxSelect Recalled by Focus Diagnostics Inc Due to Focus Diagnostics is recalling the Stratify JCV Dx...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Focus Diagnostics Inc directly.
Affected Products
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Quantity: 300 units
Why Was This Recalled?
Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
Where Was This Sold?
Internationally: Denmark only.
About Focus Diagnostics Inc
Focus Diagnostics Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report