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HardyFlask™
HARDY DIAGNOSTICS · Model X28 · UDI-DI 00819398024266
10
510(k) clearances
3,141
Adverse events
2
Recalls
17
Facilities
Description
Middlebrook 7H11 Selective, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H11 Agar is recommended for use in 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.