FDA-Device2015-04-29Class II
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Focus Diagnostics Inc
Hazard
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.
Sold states
Internationally: Denmark only.
Affected count
300 units
Manufactured in
11331 Valley View St, Cypress, CA, United States
Products
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1454-2015Don't want to check this manually?
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