Chemmette Reagents 300145Recalls & reported problems
Microbiologics Inc. · Potassium Hydroxide (KOH 10%) Chemette · Class 1
Data updated Oct 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 1, 2021Class IITerminated
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Z-2450-2021 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Other Discs, strips and reagents, microorganism differentiation devices
- API® LISTERIA 10300Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall13 reports
- NIT 1 + NIT 2 70442Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- JAMES 70542Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- VP 1 + VP 2 70422Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- RAPID ID 32 STREPBiomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION5 reports
- API® 20 STREP 20600Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION4 reports
- BD BBL™ DMACA Indole Reagent Droppers 261187Becton, Dickinson And Company · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION4 reports
- BD BBL™ DrySlide™ Oxidase 231746Becton, Dickinson And Company · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION3 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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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