NA R04033Recalls & reported problems
Remel, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 still open.
4 other recalls cover devices cleared under the same FDA submission (K892928); 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
- May 31, 2023Open, Classified
The test medium may not perform as intended.
Z-2038-2023 · Root cause: Under Investigation by firm · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K892928. One submission often covers many models, so check the product and lot details in each record.
- Z-1424-2021 · Mar 10, 2021 · Open, ClassifiedRemel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and L
- Z-1425-2021 · Mar 10, 2021 · Open, ClassifiedRemel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and
- Z-2929-2011 · Apr 21, 2011 · Terminatedremel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and L
- Z-2928-2011 · Apr 21, 2011 · Terminatedremel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and L
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 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
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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