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VITEK® 2 AST-N801 VITEK ® 2 AST-N801Recalls & 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 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

  1. Nov 9, 2022Class IIOpen, Classified

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    Z-0856-2023 · Root cause: Storage · Recall details · FDA record ↗

Other SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices

All SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page