HardyCHROM™ G307Recalls & reported problems
Hardy Diagnostics · HardyCHROM™ MRSA A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE. · 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.
1 other recall cover devices cleared under the same FDA submission (K102922); they may or may not involve this specific model.
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
- Nov 14, 2019Terminated
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Z-2298-2020 · Root cause: Nonconforming Material/Component · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K102922. One submission often covers many models, so check the product and lot details in each record.
- Z-2463-2015 · Jul 9, 2015 · TerminatedHardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro
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
- CHROMID® VRE Agar chromID™ VRE AgarBiomerieux SA · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
- NA G14Hardy Diagnostics · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page