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N/A
HARDY DIAGNOSTICS · Model J102 · UDI-DI 00816576026388
10
510(k) clearances
298
Adverse events
24
Recalls
30
Facilities
Description
BBE / LKV, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bacteroides Bile Esculin Agar (BBE) is recommended for use in the rapid isolation and presumptive identification of Bacteroides fragilis group. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
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.