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N/A
HARDY DIAGNOSTICS · Model K255 · UDI-DI 00819398021234
10
510(k) clearances
34
Adverse events
2
Recalls
18
Facilities
Description
BHI with CIPRO 10µg/mL, 5mL, 15x103mm tube, 20 tubes/pack (Brain Heart Infusion Broth wtih ciprofloxacin, 10µg/mL) For use as a pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-14 | Remel, Inc | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples |
| 2003-08-11 | Becton Dickinson & Co. | Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci. |
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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.