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Focus Diagnostics Inc recalls STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vi
Recalled April 29, 2015 · FDA recall Z-1454-2015 · Focus Diagnostics
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. · FDA Class II
Units
300 units
Sold at
Internationally: Denmark only.
Description
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.
Product
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Manufacturer(s)
Focus Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →