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N/A

HARDY DIAGNOSTICS · Model Q12 · UDI-DI 00819398022736

JSH
10
510(k) clearances
181
Adverse events
2
Recalls
30
Facilities

Description

Corn Meal Agar with Tween® 80 Deep, for chlamydospores, 18ml deep, 20x125mm pour tube, order by the package of 20 For the cultivation of fungi. Induces chlamydospore formation by Candida spp.

Recalls

DateFirmReason
2025-07-11Remel, IncThe products may contain surface and subsurface contamination of Listeria monocytogenes.
2017-03-24Remel IncConfirmed complaint of surface contamination of Listeria monocytogenes.

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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.