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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Cytospin Collection Fluid · UDI-DI 00673693235877

510(k) clearances

Adverse events

Recalls

Facilities

Description

Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.

Recalls

Date	Firm	Reason
2025-12-12	Hologic, Inc	Fungal contamination of affected lot with Parengyodontium album.
2015-04-29	Richard-Allan Scientific Company	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o
2015-04-29	Richard-Allan Scientific Company	Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o
2012-02-20	Leica Biosystems Richmond Inc.	Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 whic

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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.