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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Zinc Formal-Fixx™ · UDI-DI 00673693228312

510(k) clearances

Adverse events

Recalls

Facilities

Description

Formal-Fixx is a variation of neutral buffered formalin with a differing buffering system. This fixative is designed especially for use with the Cytoblock processing gel. The phosphate-free buffering system prevents the formation of free formic acid, and its associated artifacts, formalin pigment. The osmolality of these fixatives allows them to be used not only for light microscopy but for electron microscopic studies as well. Zinc Formal-Fixx Concentrate is the same formulation as Formal-Fixx Concentrate but includes the mineral zinc to enhance the nuclear detail of the specimen.

Recalls

Date	Firm	Reason
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17	Richard-Allan Scientific Company	The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

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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.