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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Single Cytofunnel™, White · UDI-DI 00673693217897

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Single Cytofunnel is a disposable sample chamber with attached brown or white filter card and cap. The device allows for a single cell deposition area of 6 mm and accommodates samples up to 0.5ml for the white filter cards and 0.4ml for the brown filter cards. The filter cards are preattached and allow for different absorbency rates. Brown filter cards are optimal for scan specimens such as cerebrospinal fluid. The stainless steel Cytoclip, available separately, are used to mount the Cytofunnel to the slide for use with the Cytospin™ Cytocentrifuge. Single Cytofunnels are single use only.

Recalls

Date	Firm	Reason
2018-06-04	Richard-Allan Scientific Company	Mislabeled product
2013-03-13	Separation Technology, Inc.	Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering a

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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.