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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Double Cytofunnel™, White · UDI-DI 00673693217880

510(k) clearances

Adverse events

Recalls

Facilities

Description

Double Cytofunnel is a disposable sample chamber with two chambers and pre-attached white filter card. It allows samples to be deposited into two deposition areas on a single slide which each measure 6 mm. The funnel can accommodate sample volumes up to 0.5 ml (0.25ml per side). Caps are also included but not necessary for use. The stainless steel Cytoclip, available separately, are used to mount the Cytofunnel to the slide for use with the Cytospin™ Cytocentrifuge. Double 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.