NA G14Recalls & reported problems
Hardy Diagnostics · BHI AGAR with VANCOMYCIN (Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For detecting vancomycin resistant Enterococcus spp. (VRE). · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Dec 21, 2020Terminated
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Z-0919-2021 · Root cause: Under Investigation by firm · FDA record ↗
Other Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar devices
- BD BBL™ CHROMagar® MRSA II 215229Becton, Dickinson And Company · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR122 reports
- CHROMID® MRSA agarBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall2 reports
- CHROMID® MRSA / CHROMID S. aureusBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall1 report
- CHROMID® CARBA agarBiomerieux SA · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR1 recall0 reports
- HardyCHROM™ G307Hardy Diagnostics · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- CHROMID® VRE Agar chromID™ VRE AgarBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- NA R01503Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- NA R04033Remel, Inc. · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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