VITEK® 2 AST-N807Recalls & reported problems
Biomerieux , Inc. · VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli · Class 2
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.
1 other recall cover devices cleared under the same FDA submission (K072038, K091899, K110106, K113200, K152075, K161217, K161227, K162737, K163563, K193299, K211630, K222073, K222378, N50510); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Mar 14, 2024Open, Classified
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Z-1464-2024 · Root cause: Employee error · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072038, K091899, K110106, K113200, K152075, K161217, K161227, K162737, K163563, K193299, K211630, K222073, K222378, N50510. One submission often covers many models, so check the product and lot details in each record.
- Z-0861-2023 · Nov 9, 2022 · Open, ClassifiedVITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Other SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices
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- BD Phoenix™ NMIC/ID-307 449289Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION529 reports
- BD Phoenix™ PMIC/ID-107 448607Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION2 recalls169 reports
- BD Phoenix™ NMIC-306 449292Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION1 recall143 reports
- VITEK® 2 AST-GP67Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls83 reports
- BD Phoenix™ AST Broth 246003Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION182 reports
- VITEK® 2 AST-GP75Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls52 reports
- VITEK® 2 AST-GP78Biomerieux , Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation2 recalls41 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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