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N/A
HARDY DIAGNOSTICS · Model K159 · UDI-DI 00819398020916
10
510(k) clearances
3,147
Adverse events
2
Recalls
17
Facilities
Description
Buffered Yeast Extract, 16x125mm Tube, 10mL. Hardy Diagnostics Buffered Yeast Extract (BYE) broth is recommended for use in the cultivation of Legionella spp. in water and other samples suspected of harboring the bacteria.
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.