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HARDY DIAGNOSTICS · Model K19 · UDI-DI 00819398020992

KZI
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities

Description

Cooked Meat Medium, 16x125mm Tube, 10ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.

Recalls

DateFirmReason
2009-02-19Becton Dickinson & Co.In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27Remel, Inc.The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

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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.