VITEK®2 8.01Recalls & reported problems
Biomerieux , Inc. · VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system · Class 2
All models of VITEK2 (5)
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
- Jul 13, 2022Open, Classified
There are 7 reported software anomalies that may affect use of the device.
Z-1640-2022 · Root cause: Software design · Recall details · FDA record ↗
Other System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices
- BD Phoenix™ M50 Automated Microbiology System 443624Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION3 recalls417 reports
- 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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