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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model PapSpin™ Collection Fluid · UDI-DI 00673693228657

510(k) clearances

Adverse events

Recalls

Facilities

Description

PapSpin™ Collection Fluid is used for the cytological fixation of gynecological samples. The collection fluid may be used independently or in conjunction with the EZ Megafunnels and Megafunnel cytoslides as found in the PapSpin™ Collection Fluid Kit.

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.