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ClearCell® FX1 Unit

BIOLIDICS LIMITED · Model CBB-F011001-C · UDI-DI 08885016030003

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.

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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.