PREVI® Color Gram RB IODINE solution 29586Recalls & reported problems
Biomerieux SA · Gram's method reagent used exclusively on PREVI Color Gram instrument North America · Class 1
Data updated Oct 18, 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.
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
- Nov 9, 2022Class IIOpen, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0793-2023 · Root cause: Storage · Recall details · FDA record ↗
Other Stains, microbiologic devices
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- BD BBL™ India Ink Reagent Droppers 261194Becton, Dickinson And Company · STAINS, MICROBIOLOGIC13 reports
- BD BBL™ Gram Crystal Violet 212525Becton, Dickinson And Company · Stains, microbiologic8 reports
- BD BBL™ Gram Stain Kit 212539Becton, Dickinson And Company · STAINS, MICROBIOLOGIC7 reports
- BD BBL™ Gram Safranin 212531Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
- BD BBL™ Gram Iodine (Stabilized) 212542Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
- BD BBL™ TB Decolorizer 212517Becton, Dickinson And Company · Stains, microbiologic4 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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