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MACCONKEY AGAR
OXOID LIMITED · Model CM0007B · UDI-DI 05032384001040
10
510(k) clearances
298
Adverse events
24
Recalls
30
Facilities
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.