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HARDY DIAGNOSTICS · Model W30 · UDI-DI 00816576027576
10
510(k) clearances
3,147
Adverse events
2
Recalls
17
Facilities
Description
Middlebrook 7H10, deep fill, 15x100mm plate, order by the package of 10 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.
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.