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RICHARD-ALLAN SCIENTIFIC COMPANY · Model Gill 1 Hematoxylin (Series R) · UDI-DI 00673693088015

510(k) clearances

Adverse events

Recalls

Facilities

Description

Gill Hematoxylin 1, 2, and 3 are rapid, progressive hematoxylins that are widely known and respected in the histology and cytology fields. They offer convenience and choice of stain intensity. Gill hematoxylins are ready to use and will provide familiar, consistent, well-delineated results. Stain filtering may be needed to remove sheen caused by oxidation or cells shed off of slides in the cytology staining process. Gill 1 is the least intense stain and is most commonly used in cytology and in special stains. Gill 2 is a moderately intense stain and is most commonly used in histology, with some limited use in cytology. Gill 3 is an intense stain and is exclusively used in histology as well as staining of plastic sections.

Recalls

Date	Firm	Reason
2017-12-19	Ventana Medical Systems Inc	Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINte

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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.