NIT 1 + NIT 2 70442Recalls & reported problems
Biomerieux SA · Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE (20 050), API® Staph (20 500), API® Coryne (20 900), API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300) · Class 1
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Nov 9, 2022Open, Classified
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0809-2023 · Root cause: Storage · Recall details · FDA record ↗
Other DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION devices
- API® LISTERIA 10300Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall13 reports
- Chemmette Reagents 300145Microbiologics Inc. · Discs, strips and reagents, microorganism differentiation1 recall0 reports
- VP 1 + VP 2 70422Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- JAMES 70542Biomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION1 recall0 reports
- RAPID ID 32 STREPBiomerieux SA · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION5 reports
- BD BBL™ DMACA Indole Reagent Droppers 261187Becton, Dickinson And Company · DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION4 reports
- API® 20 STREP 20600Biomerieux SA · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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