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AnaeroGRO

HARDY DIAGNOSTICS · Model AG23H · UDI-DI 00819398020091

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

Description

Thioglycollate with H and K, 16x125mm Tube with Hungate Septum Cap, 7ml. Hardy Diagnostics AnaeroGRO™ Thioglycollate with Hemin and Vitamin K (H and K) is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms.

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.