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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Three-Step Solution B · UDI-DI 00673693069717

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Three-Step Stain Set is comprised of three components: a methanol fixative (Fixative), an aqueous eosin solution (Solution A), and an aqueous methylene blue/azure A solution (Solution B). The staining solutions consist of xanthene and thiazine dyes, exhibiting both anionic and cationic properties, respectively. Cationic cellular components, such as erythrocytes and eosinophilic granules, share an affinity for the anionic dye of Solution A. The negatively charged phosphate groups of DNA and basophilic granules of the cytoplasm have an affinity for the polychromatic cationic dyes of Solution B. The aqueous stain formulations function to dissociate and activate the dye ions, allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solutions is a critical factor

Recalls

Date	Firm	Reason
2017-03-15	Richard-Allan Scientific Company	Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

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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.