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Cytopro® Rotor

ELITECHGROUP INC. · Model AC-160 · UDI-DI 03661540301179

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Cytopro Cytocentrifuge rotor is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. It is an accessory for use with any Elitech Group Aerospray Slide Stainer/Cytocentrifuge. This manual pertains only to the Series 2 stainer/cytocentrifuge models.

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.