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Cytopro® Cytocentrifuge

ELITECHGROUP INC. · Model Model 7622 · UDI-DI 03661540303975

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

Description

TThe Cytopro Cytocentrifuge is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. The Cytopro can be used with the following cell suspensions: Bronchoalveolar liquid (BAL), Cerebrospinal fluid (CSF), Urine, Synovial fluid, And many more.

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.