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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Zinc Buffered Formalin Prefilled Container · UDI-DI 00673693084338

LDY
1
510(k) clearances
1
Adverse events
7
Recalls
22
Facilities

Description

Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in certain circumstances, other fixatives may be desired according to tissue type or subsequent pretreatment or staining technique. Zinc Buffered Formalin maintains the traditional formulation of 10% Neutral Buffered Formalin but with the addition of zinc. The addition of zinc provides better nuclear detail in tissue samples.

Recalls

DateFirmReason
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe affected lots could have NBF concentrations that are lower or higher than the desired specifications.
2014-09-17Richard-Allan Scientific CompanyThe 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.