FDA Device Intelligence
HomeCytogen, Inc. › Cell Isolator V2

Cell Isolator V2

Cytogen, Inc. · Model CIS060 · UDI-DI 08800021900172

GKH
10
510(k) clearances
51
Adverse events
2
Recalls
5
Facilities

Recalls

DateFirmReason
2010-05-19Veridex, LLCComplaints of patient sample carryover.
2009-05-06Veridex, LLCBottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

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.