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N/A
HARDY DIAGNOSTICS · Model L49 · UDI-DI 00819398022378
10
510(k) clearances
535
Adverse events
6
Recalls
24
Facilities
Description
Inhibitory Mold Agar with Gentamicin Slant, 10ml, 20x125mm tube, order by the package of 20 (Inhibitory Mold Agar with Gentamicin) For the selective isolation of pathogenic fungi.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-05 | Remel, Inc | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. |
| 2018-08-02 | Acumedia Manufacturers, Inc. | The product is labeled with an incorrect expiration date. |
| 2016-03-21 | Hardy Diagnostics | Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to produc |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
| 2013-06-06 | Becton Dickinson & Co. | Microbiological identification media may exhibit reduced levels of Vancomycin. |
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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.
