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HardyCHROM
HARDY DIAGNOSTICS · Model J119 · UDI-DI 00816576026524
10
510(k) clearances
181
Adverse events
2
Recalls
30
Facilities
Description
Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-11 | Remel, Inc | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| 2017-03-24 | Remel Inc | Confirmed complaint of surface contamination of Listeria monocytogenes. |
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Get your free API keyRead the docsData 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.