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HARDY DIAGNOSTICS · Model L27 · UDI-DI 00819398022170

JSI

510(k) clearances

298

Adverse events

Recalls

Facilities

Description

DTM (Dermatophyte Test Media) Agar Slant, 7.5ml Slant, order by the package of 20 (Dermatophyte Test Medium) For the isolation and identification of dermatophytic fungi such as Microsporum canis, the causative agent of ringworm. It is also designed to detect dermatophytes such as Epidermophyton and Trichophyton spp. The addition of Gentamicin and Chlortetracycline act as broad spectrum antimicrobics to inhibit a wide range of interfering gram-positive and gram-negative bacteria. Cycloheximide is added to inhibit saprophytic non-pathogenic fungi. Phenol red, the pH indicator, is affected by the presence of dermatophytes (Epidermophyton, Microsporum, and Trichophyton spp.), which all produce alkaline metabolites. Vials are made of shatter resistant polycarbonate plastic with a wide mouth opening for easy inoculatio

Recalls

Date	Firm	Reason
2025-07-11	Remel, Inc	The products may contain surface and subsurface contamination of Listeria monocytogenes.
2025-07-11	Remel, Inc	The products may contain surface and subsurface contamination of Listeria monocytogenes.
2025-07-11	Remel, Inc	The products may contain surface and subsurface contamination of Listeria monocytogenes.
2025-04-24	Mckesson Medical-Surgical Inc. Corporate Office	transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2025-02-13	Remel, Inc	Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood si
2025-02-13	Remel, Inc	Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood si
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2020-12-10	Remel Inc	The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
2018-08-02	Acumedia Manufacturers, Inc.	Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.

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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.