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N/A
HARDY DIAGNOSTICS · Model C42 · UDI-DI 00819398020336
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities
Description
Middlebrook 7H10 with Human Blood, 10ml Slant. Hardy Diagnostics Middlebrook 7H10 Agar with Human Blood is recommended for use in the isolation and cultivation of Mycobacterium spp., including M. genavense.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-02-19 | Becton Dickinson & Co. | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. |
| 2004-09-27 | Remel, Inc. | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
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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.