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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Paraffin, Type L · UDI-DI 00673693089043

KEO
10
510(k) clearances
1
Adverse events
3
Recalls
25
Facilities

Description

The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.

Recalls

DateFirmReason
2014-04-16Sakura Finetek USA IncThis Lot has variations in melting temperature.
2010-01-22Abbott MolecularThe Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
2010-01-22Abbott MolecularThe Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.

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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.