Focus Diagnostics Inc recalls STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vit…

Recall date

March 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1454-2015

FDA classification

Class II

Brand / firm

Focus Diagnostics Inc

Sold / distributed

Internationally: Denmark only.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.