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STRATIFY JCV™ DXSELECT™

DIASORIN MOLECULAR LLC · Model EL1950-5 · UDI-DI 20816101022261

OYP Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
2
Facilities

Recalls

DateFirmReason
2015-03-15Focus Diagnostics IncFocus 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 po

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.