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Non Gyn Only ThinPrep Genesis Processor

Hologic, Inc. · Model Non Gyn Only ThinPrep Genesis Processor · UDI-DI 15420045512481

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

Description

Processes Non Gyn specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.

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.