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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model EA-65 Papanicolaou Stain · UDI-DI 00673693088367

510(k) clearances

Adverse events

Recalls

Facilities

Description

EA-36, -50, -65 and Modified EA are ready-to-use cytoplasmic counterstains used for gynecological and non-gynecological cytology specimens. These products contain common dyes and reagent solvents used in traditional EA formulations. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results. Cellular results are traditional as well, with basal or intermediate cells staining a blue-green hue and surface cells staining a pink-red hue. This multicolored effect is due to dye uptake by various cells and their affinities for the specific dyes. EA-65 is used in conjunction with OG-6 for the staining of non-gynecological specimens. This formulation contains less dye resulting in lighter staining of highly mucoid sample types common in non-gynecological cytology.

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.