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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model UniSystem Collection Pack · UDI-DI 00673693220118

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

Description

The UniSystem tubes are disposable, polystyrene tubes graduated to 12 mL, with unique patented tips designed to retain a standardized 0.4 mL volume of sediment or liquid when decanted. Up to 10 tubes can be simultaneously decanted by using the UniSystem Rack or tubes can be individually decanted by hand.

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.