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HER2 Dual ISH 3-in-1 Xenograft Slides

Ventana Medical Systems, Inc. · Model 05640300001 · UDI-DI 04015630972524

KIR Prescription
10
510(k) clearances
1
Adverse events
1
Recalls
7
Facilities

Recalls

DateFirmReason
2009-01-21Diagnostic Hybrids IncDuring QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cel

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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.