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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model PrintMate™ Slotted Cassette · UDI-DI 00673693757706

IDZ
5
510(k) clearances
48
Adverse events
1
Recalls
57
Facilities

Description

Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

Recalls

DateFirmReason
2013-04-04Leica Microsystems, Inc.An LPC Fine Mesh Cassette failed to stay closed during processing operations.

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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.