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N/A
HARDY DIAGNOSTICS · Model K36 · UDI-DI 00819398021418
10
510(k) clearances
173
Adverse events
2
Recalls
29
Facilities
Description
Malonate Broth, 5mL, 15x103mm tube, 20 tubes/pack For the differentiation of gram negative bacilli based on malonate utilization.
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.