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HARDY DIAGNOSTICS · Model K02 · UDI-DI 00819398020619

510(k) clearances

Adverse events

Recalls

Facilities

Description

Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and selective medium for the isolation and cultivation of Trichomonas species from clinical specimens, especially T. vaginalis.

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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Data 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.