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N/A
HARDY DIAGNOSTICS · Model G263 · UDI-DI 00816576025596
10
510(k) clearances
298
Adverse events
24
Recalls
30
Facilities
Description
EMB Agar (HHT), 15x100mm Plate, 20ml. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
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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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.