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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model TPX Sample Chamber Closure Caps · UDI-DI 00673693226943

IFB
3
510(k) clearances
12
Adverse events
2
Recalls
17
Facilities

Description

The TPX Sample Chamber is a reusable sample chamber used in conjunction with a closure cap, Cytoclip and 2-hole disposable filter card (Brown) and (White). The Cytoclip is used to mount the Cytofunnel to the Cytospin™ Cytocentrifuge. The filter cards are designed with two cut-outs for easy insertion with the TPX chamber although only one deposition area is visualized. TPX chambers are reusable and autoclavable.

Recalls

DateFirmReason
2018-06-04Richard-Allan Scientific CompanyMislabeled product
2013-03-13Separation 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.