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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Modified Grocott’s Methenamine Silver Stain Kit · UDI-DI 00673693089180

JTS

510(k) clearances

253

Adverse events

Recalls

Facilities

Description

"Fungal cell walls are rich in polysaccharides known as glucans. Periodic Acid Solution oxidizes these polysaccharides to form aldehydes, which in turn react with the silver ions present in the Working Methenamine Silver Solution and reduce them to form visible metallic silver. Gold Chloride Solution tones the sections and intensifies the reduced silver by forming a silver-gold complex. Sodium Thiosulfate Solution removes any unreduced silver from the tissue sections, followed by Fast Green Stain Solution which produces a light green background to further enhance contrast."

Recalls

Date	Firm	Reason
2025-02-12	Becton Dickinson & Co.	One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
2020-04-14	Becton Dickinson & Co.	May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stai
2020-04-14	Becton Dickinson & Co.	May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stai
2020-04-14	Becton Dickinson & Co.	May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stai
2018-03-23	BioMerieux SA	A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux di
2014-10-29	Remel Inc	The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
2012-04-12	Becton Dickinson & Co.	Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
2012-04-12	Becton Dickinson & Co.	Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
2004-09-29	Becton Dickinson & Co.	Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.

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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.