Home › HARDY DIAGNOSTICS › N/A
N/A
HARDY DIAGNOSTICS · Model K08 · UDI-DI 00819398020657
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities
Description
BHI Broth with Fildes, 16x125mm Tube, 10ml. Brain Heart Infusion (BHI) Broth enriched with Fildes is useful for cultivating capsular strains of Haemophilusinfluenzae.
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) |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.