FDA Device Intelligence
Home › ABBOTT MOLECULAR INC. › Vysis

Vysis

ABBOTT MOLECULAR INC. · Model 07J22-050 · UDI-DI 00884999027091

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

Description

Vysis CEP X SpectrumOrange/ Y SpectrumGreen

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.