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Epredia

SHANDON DIAGNOSTICS LIMITED · Model Cytospin 4 Starter Kit · UDI-DI 05051663518345

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

Description

Cytospin 4 Cytocentrifuge - Accessory

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.