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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Cyto-Stain ™ · UDI-DI 00673693088244

510(k) clearances

Adverse events

Recalls

Facilities

Description

Cyto-Stain™ acts as a single-solution cytoplasmic stain, producing the full range of familiar colors seen in conventional Papanicolaou staining and providing complete control of staining intensity. The staining of Cyto-Stain™ is accomplished through a formulation based upon the differential affinities of its component dyes for various cellular components. Final cytoplasmic hues are influenced by both the prior action of Clarifier 1 and the subsequent 95% alcohol rinses. Cyto-Stain™ produces results comparable to Pap staining with one minor difference: cilia in bronchial washings stain blue-green with Cyto-Stain™ rather than red as seen in traditional Pap staining procedures

Recalls

Date	Firm	Reason
2015-02-19	Richard-Allan Scientific Company	The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and
2002-12-13	EMD Chemicals Inc	Difficulty in reading slides due to the stain is much greener than normal.

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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.