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ONCORE Pro Hematoxylin

BIOCARE MEDICAL LLC · Model OPRI6087T60 · UDI-DI 00847627034830

HYJ
10
510(k) clearances
7
Adverse events
1
Recalls
40
Facilities

Recalls

DateFirmReason
2017-12-19Ventana Medical Systems IncIncreased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINte

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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.