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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Gram Stain Kit - Film · UDI-DI 00673693089258

JTS

510(k) clearances

253

Adverse events

Recalls

Facilities

Description

"Gram Stain Kits – Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have thick cell walls with high peptidoglycan content, whereas Gram-negative bacteria have thin cell walls with low peptidoglycan content. Both Gram-positive and Gram-negative bacteria stain with the dye- lake formed by Crystal Violet Solution and Gram’s Iodine Solution. However, during rinsing with Decolorizing Solution, this dye-lake is completely removed from the thin-walled Gram- negative bacteria, allowing them to be subsequently stained with Safranin O Stain Solution. The short duration of the decolorization step enables Gram-positive bacteria to retain the crystal violet dye-lake. Care should be taken when rinsing slides with Decolorizing Solution, as extended rinses can cause the crystal violet dye-lake to be removed from Gram-positive bacteria in addition to Gram-negative bacteria. Within the Tissue Kit only, tissue elements are then counterstained yellow by Tartrazine Stain Solution."

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.