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FDAMarch 15, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

focus diagnosticsfocus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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